UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORM 10-K

(MarkOne)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934

Forthe fiscal year ended December 31, 2020

or

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Forthe transition period from __________________________ to __________________________

Commissionfile number 001-38416

ORGENESISINC.

(Exactname of registrant as specified in its charter)

Nevada		98-0583166
State or other jurisdiction		(I.R.S. Employer
of incorporation or organization		Identification No.)

20271Goldenrod Lane , Germantown , MD 20876

(Addressof Principal Executive Offices) (Zip Code)

Registrant’stelephone number, including area code: (480) 659-6404

Securitiesregistered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		ORGS		The Nasdaq Capital Market

Securitiesregistered pursuant to Section 12(g) of the Act: None

Indicateby check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicateby check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicateby check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicateby check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuantto Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period thatthe registrant was required to submit such files). Yes ☒ No ☐

Indicateby check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smallerreporting company ☒
Emerging growth company ☐

Ifan emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicateby check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectivenessof its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registeredpublic accounting firm that prepared or issued its audit report. ☐

Indicateby check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

Theregistrant had 24,199,674 shares of common stock outstanding as of March 9, 2021. The aggregate market value of the commonstock held by non-affiliates of the registrant as of the last business day of the registrant’s most recently completed secondfiscal quarter (June 30, 2020) was $ 105,399,427 ,as computed by reference to the closing price of such common stock on The Nasdaq Capital Market on such date.

ORGENESISINC.

2020FORM 10-K ANNUAL REPORT

TABLEOF CONTENTS

	Page
PART I
ITEM 1. BUSINESS	5
ITEM 1A. RISK FACTORS	21
ITEM 1B. UNRESOLVED STAFF COMMENTS	42
ITEM 2. PROPERTIES	42
ITEM 3. LEGAL PROCEEDINGS	43
ITEM 4. MINE SAFETY DISCLOSURES	43
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	43
ITEM 6. SELECTED FINANCIAL DATA	45
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	45
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	61
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	61
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	61
ITEM 9A. CONTROLS AND PROCEDURES	61
ITEM 9B. OTHER INFORMATION	62
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	62
ITEM 11. EXECUTIVE COMPENSATION	67
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	73
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	76
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES	77
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES	78
ITEM 16. FORM 10-K SUMMARY	81
SIGNATURES	82

FORWARD-LOOKINGSTATEMENTS

CAUTIONARYSTATEMENT FOR PURPOSES OF THE “SAFE HARBOR” PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Thefollowing discussion should be read in conjunction with the financial statements and related notes contained elsewhere in thisAnnual Report on Form 10-K. Certain statements made in this discussion are “forward-looking statements” within themeaning of 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the SecuritiesExchange Act of 1934, as amended. These statements are based upon beliefs of, and information currently available to, the Company’smanagement as well as estimates and assumptions made by the Company’s management. Readers are cautioned not to place unduereliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. When used herein,the words “anticipate,” “believe,” “estimate,” “expect,” “forecast,”“future,” “intend,” “plan,” “predict,” “project,” “target,”“potential,” “will,” “would,” “could,” “should,” “continue”or the negative of these terms and similar expressions as they relate to the Company or the Company’s management identifyforward-looking statements. Such statements reflect the current view of the Company with respect to future events and are subjectto risks, uncertainties, assumptions, and other factors, including the risks relating to the Company’s business, industry,and the Company’s operations and results of operations. Should one or more of these risks or uncertainties materialize,or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed,estimated, expected, intended, or planned.

Althoughthe Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guaranteefuture results, levels of activity, performance, or achievements. Except as required by applicable law, including the securitieslaws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statementsto actual results.

Ourfinancial statements are prepared in accordance with accounting principles generally accepted in the United States (“GAAP”).These accounting principles require us to make certain estimates, judgments and assumptions. We believe that the estimates, judgmentsand assumptions upon which we rely are reasonable based upon information available to us at the time that these estimates, judgmentsand assumptions are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilitiesas of the date of the financial statements as well as the reported amounts of revenues and expenses during the periods presented.Our financial statements would be affected to the extent there are material differences between these estimates and actual results.The following discussion should be read in conjunction with our financial statements and notes thereto appearing elsewhere inthis report.

Unlessotherwise indicated or the context requires otherwise, the words “we,” “us,” “our,” the “Company,”“our Company” or “Orgenesis” refer to Orgenesis Inc., a Nevada corporation, and our majority or wholly-ownedsubsidiaries, Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), (formerly known as CureCell); Orgenesis BelgiumSRL, a Belgian-based entity (the “Belgian Subsidiary”); Orgenesis Ltd., an Israeli corporation (the “IsraeliSubsidiary”); Orgenesis Maryland Inc., a Maryland corporation (the “U.S. Subsidiary”); Orgenesis SwitzerlandSarl, which was incorporated in October 2020 (the “Swiss Subsidiary”); Orgenesis Biotech Israel Ltd. (formerly knownas Atvio Biotech Ltd.) (“OBI”); Koligo Therapeutics Inc., a Kentucky corporation, purchased in 2020 (“Koligo”);Masthercell Global Inc. (“Masthercell”) and its wholly owned subsidiaries Cell Therapy Holdings S.A., MaSTherCell,S.A. (“MaSTherCell”), a Belgian-based subsidiary and a Contract Development and Manufacturing Organization (“CDMO”)specialized in cell therapy development and manufacturing for advanced medicinal products, and Masthercell U.S., LLC (“MasthercellU.S.”), a U.S.-based CDMO (collectively, “Masthercell”). The Company sold all of its equity interests in Masthercelland its subsidiaries on February 20, 2020.

Forward-lookingstatements made in this Annual Report on Form 10-K include statements about:

Corporateand Financial

●	our ability to increase revenues;
●	our ability to achieve profitability;
●	our ability to manage our research and development programs that are based on novel technologies;
●	our ability to grow the size and capabilities of our organization through further collaboration and strategic alliances to expand our point-of-care cell therapy business;
●	our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties;
●	our ability to manage potential disruptions as a result of the coronavirus outbreak;
●	our ability to manage the growth of our company;
●	our ability to attract and retain key scientific or management personnel and to expand our management team;
●	the accuracy of estimates regarding expenses, future revenue, capital requirements, profitability, and needs for additional financing; and
●	our belief that our therapeutic related developments have competitive advantages and can compete favorably and profitably in the cell and gene therapy industry.

Cell& Gene Therapy Business (“CGT”)

●	our ability to adequately fund and scale our various collaboration, license, partnership and joint venture agreements for the development of therapeutic products and technologies;
●	our ability to advance our therapeutic collaborations in terms of industrial development, clinical development, regulatory challenges, commercial partners and manufacturing availability;
●	our ability to implement our point-of-care cell therapy (“POC”) strategy in order to further develop and advance autologous therapies to reach patients;
●	expectations regarding our ability to obtain additional and maintain existing intellectual property protection for our technologies and therapies;
●	our ability to commercialize products in light of the intellectual property rights of others;
●	our ability to obtain funding necessary to start and complete such clinical trials;
●	our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements;
●	our belief that our systems and therapies are as at least as safe and as effective as other options;
●	our Subsidiary’s relationship with Tel Hashomer Medical Research Infrastructure and Services Ltd. (“THM”) and the risk that THM may cancel or, at the very least continue to challenge, the License Agreement with Orgenesis Ltd. as we continue to expand our focus to other therapies;
●	our license agreements with other institutions;
●	expenditures not resulting in commercially successful products;
●	our dependence on the financial results of our POC business; and
●	our ability to grow our POC business and to develop additional joint venture relationships in order to produce demonstrable revenues.

Thesestatements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in thesection entitled “Risk Factors” set forth in this Annual Report on Form 10-K for the year ended December 31, 2020,any of which may cause our Company’s or our industry’s actual results, levels of activity, performance or achievementsto be materially different from any future results, levels of activity, performance or achievements expressed or implied by theseforward-looking statements. These risks may cause the Company’s or its industry’s actual results, levels of activityor performance to be materially different from any future results, levels of activity or performance expressed or implied by theseforward looking statements.

Althoughwe believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results,levels of activity or performance. Moreover, neither we nor any other person assumes responsibility for the accuracy and completenessof these forward-looking statements. The Company is under no duty to update any forward-looking statements after the date of thisreport to conform these statements to actual results.

PARTI

ITEM1. BUSINESS

BusinessOverview

OrgenesisInc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies in an affordableand accessible format (“CGTs”).

CGTscan be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are partof a class of medicines referred to as advanced therapy medicinal products (ATMPs). We mostly focus on autologous therapies, withprocesses and systems that are developed for each therapy using a closed and automated processing system approach that is validatedfor compliant production near the patient at their point of care for treatment of the patient. This approach has the potentialto overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial productionof advanced therapies due to their cost prohibitive nature and complex logistics to deliver the treatments to patients (ultimatelylimiting the number of patients that can have access to, or can afford, these therapies).

Toachieve these goals, we have developed a Point of Care Platform comprised of three enabling components: a pipeline of licensed POCare Therapies that are designed to be processed and produced in closed, automated POCare Technology systems acrossa collaborative POCare Network . Via a combination of science, technology, engineering, and networking, we are working toprovide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. We alsodraw on extensive medical expertise to identify promising new autologous therapies to leverage within the POCare Platform eithervia ownership or licensing.

ThePOCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide with a goal ofachieving harmonized, regulated clinical development and production of the therapies.

POCarePlatform Operations via Subsidiaries

Wecurrently conduct our core business operations ourselves and through our subsidiaries which are all wholly-owned except as otherwisestated below (collectively, the “Subsidiaries”). The Subsidiaries are as follows:

UnitedStates

●	Orgenesis Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America and is currently focused on setting up the POCare Network.
●	Koligo Therapeutics Inc. (“Koligo”) is a Kentucky corporation that we acquired in 2020 and is currently focused on developing the POCare network and therapies. .

Europe

●	Orgenesis Belgium SRL (the “Belgian Subsidiary”) is the center of activity in Europe and is currently focused on process development and the preparation of European clinical trials.
●	Orgenesis Switzerland Sarl (the “Swiss Subsidiary”), was incorporated in October 2020, and is currently focused on providing management services to us.

Asia

●	Orgenesis Ltd. in Israel (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services.
●	Orgenesis Biotech Israel Ltd. (“OBI”), is a provider of cell-processing services in Israel.
●	Korea: Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), is a provider of processing and pre-clinical services in Korea. We own 94.12% of the Korean Subsidiary.

DiscontinuedOperations

UntilDecember 31, 2019, we operated the POCare Platform as one of two business separate business segments.

Historically,the second separate business segment was operated as a Contract Development and Manufacturing Organization (“CDMO”)platform, providing contract manufacturing and development services for biopharmaceutical companies (the “CDMO Business”).The CDMO platform was historically operated mainly through majority owned Masthercell Global (which consisted of the followingtwo subsidiaries: MaSTherCell S.A. in Belgium (“MaSTherCell”), and Masthercell U.S., LLC in the United States (“MasthercellU.S.”) (collectively, the “Masthercell Global Subsidiaries”)).

InFebruary 2020, we and GPP-II Masthercell LLC (“GPP”) sold 100% of the outstanding equity interests of Masthercell(the “Masthercell Business”), which comprised the majority of our CDMO Business, to Catalent Pharma Solutions, Inc.for an aggregate nominal purchase price of $315 million, subject to customary adjustments (the “Masthercell Sale”).After accounting for GPP’s liquidation preference and equity stake in Masthercell as well as other investor interests inour Belgian subsidiary MaSTherCell, distributions to Masthercell option holders and transaction costs, we received approximately$126.7 million. We incurred an additional approximately $5.6 million in transaction costs.

Wedetermined that the Masthercell Business (“Discontinued Operation”) meets the criteria to be classified as a discontinuedoperation as of the first quarter of 2020. The Discontinued Operation includes the vast majority of the previous CDMO Business,including majority-owned Masthercell, including MaSTherCell, Masthercell U.S. and all of the Masthercell Global Subsidiaries.

Sincethe Masthercell Sale, we entered into new joint venture agreements with new partners in various jurisdictions. This has allowedus to grow our infrastructure and expand our processing sites into new markets and jurisdictions. In addition, we have engagedsome of these joint venture partners to perform research and development services to further develop and adapt our systems anddevices for specific purposes. We have been investing manpower and financial resources to focus on developing, manufacturing androlling out several types of OMPULs to be used and/or distributed through our POCare Network of partners, collaborators, and jointventures.

The Chief Executive Officer(“CEO”) is the Company’s chief operating decision-maker who reviews financial information prepared on a consolidatedbasis. Effective from the first quarter of 2020, all of our continuing operations are in the point-of-care business via ourPOCare Platform. Therefore, no segment report has been presented.

AdvancedTherapy Medicinal Products (ATMPs) Overview

AdvancedTherapy Medicinal Product (“ATMP”) means one of any of the following medicinal products that are developed and commercializedfor human use:

●	A somatic cell therapy medicinal product (“STMP”) that contains cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body.
●	A tissue engineered produc t (“TEP”) that contains cells or tissues that have been modified so that they can be used to repair, regenerate, or replace human tissue.
●	A gene therapy medicinal product (“GTMP”) that engineers genes that lead to a therapeutic, prophylactic, or diagnostic effect and, in many cases, work by inserting “recombinant” genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer, or long-term diseases. In this case, a recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources.

Itis important to note that although STMPs and GTMPs currently dominate the market, in order to access the market potential andtrends in the future, other cell products are likely to be essential in all of these categories.

Webelieve that autologous therapies represent a substantial segment of the ATMP market. Autologous therapies are produced from apatient’s own cells versus allogeneic therapies that are mass-cultivated from donor cells via the construction of masterand working cell banks, are then produced on a large scale. Developers and manufacturers of ATMPs (both autologous and allogeneic)currently rely heavily on production using traditional centralized supply chains and manufacturing sites.

CGTsare costly and complex to produce. We also refer to CGTs as “living” drugs since they are based on maintaining thecells vitality. Therefore, there is no possibility to sterilize the products, since such a process involves killing any livingorganism. Many of these therapies require sourcing of the patient’s cells, engineering them in a sterile environment andthen transplanting them back to the patient (so-called “autologous” CGT). This presents multiple logistic challengesas each patient requires its own production batch, and the current processes involve complex laboratory-based types of manipulationsrequiring highly trained lab technicians. We are leveraging a unique approach to therapy production using the POCare Platformto potentially overcome some of the development and supply chain challenges of affordably bringing autologous therapies to patients.

Allogeneictherapies are costly and complex to produce because autologous therapies are derived from the treated patient and manufacturedthrough a defined protocol before re-administration. We are leveraging a unique approach to therapy production using the POCarePlatform to potentially overcome some of the development and supply chain challenges of bringing autologous therapies to patientsaffordably.

OurTherapies

Productsin Clinical Use

KYSLECEL®(autologous Pancreatic Islets)

KYSLECELis made from a patient’s own pancreatic islets – the cells that make insulin to regulate blood sugar. KYSLECEL isintended to preserve insulin secretory capacity in chronic or acute recurrent pancreatitis patients after total pancreatectomy(TP-IAT). KYSLECEL is a minimally manipulated autologous cell-based product available in the United States and regulated by theFood and Drug Administration (“FDA”). KYSLECEL is produced according to current good tissue practices (cGTP) and incompliance with federal and state regulations. Prior to being acquired by us, Koligo treated approximately 40 patients with KYSLECELat six U.S. hospitals through a commercial pilot program.

TissueGenesis Icellator® for Cell Assisted Lipotransfer

TheTissue Genesis Icellator is a point-of-care medical device that isolates stromal and vascular fraction cells (“SVF”)from a patient’s own (autologous) adipose tissue (fat). The Icellator is commercially available in Korea through a medicaldevice distributor. The SVF obtained from the Icellator is for use in cell-assisted lipotransfer, a plastic surgery procedureintended to improve fat engraftments.

Itis expected that the Icellator may also become commercially available in Japan in 2021 for use in cell assisted lipotransfer,pending review and approval by the Japanese Pharmaceuticals and Medical Devices Agency.

Cartil-SAutologous Products for the Treatment of Osteoarthritis

Cartil-Sis a cell therapy for Osteoarthritis. This product is produced by performing a minimally invasive biopsy of adipose (fat) tissuefrom a patient, followed by isolation and expansion of adipose-derived stem cells (ADSCs), to be injected arthroscopically. Theautologous injectable product helps delay/stop the progression of osteoarthritis, involving the patient’s own stem cells.

ChondrosealAutologous Products for the Treatment of Cartilage Defects (Osteoarthritis)

Chondrosealis a cell therapy for cartilage defects. Following collection of adipose tissue by minimally invasive biopsy that is composedof ADSCs, the cells are combined with a natural gel serving as a scaffold for local cartilage regeneration in the joint.

Productsin Clinical Development

Thefollowing chart depicts our therapeutic development pipeline.

Productsin Clinical Trials

RanTop,Ranpirnase Topical Formulation

Weare currently developing a novel topical formulation of an active RNA-degrading enzyme, called Ranpirnase. Ranpirnase combatsviral infections by targeting double-stranded RNA including miRNA precursors, via RNA degradation catalysis. It acts through adual mechanism: 1) Inhibition of viral replication; and 2) induction of host cell apoptosis. Ranpirnase was previously developedfor the treatment of human papillomavirus (HPV)-related pathologiessuch as external genital warts (EGW) and anal dysplasia. It has demonstrated clinical efficacy and good tolerability in a PhaseIIa clinical study for the treatment of HPV-associated EGW. The initiation of a clinical Phase IIb for EGW is planned for 2021.

TissueGeneseis Icellator® for Erectile Dysfunction and COVID-19 (SVF-CLI-ED)

Thesafety of the Tissue Genesis Icellator, and use of SVF produced by the Icellator, has previously been tested in a number of pilotclinical trials in the United States. Orgenesis has prioritized the clinical development of the Icellator for potential use inthe treatment of erectile dysfunction and COVID-19 related respiratory complications. Pending review and approval of the FDA ofthe clinical trials, we expect to start a phase 2 trial in erectile dysfunction and a phase 1 trial for COVID -19 in 2021.

TheTissue Genesis Icellator is also being used by research collaborators in FDA-regulated clinical trials to test the use of SVFduring rotator cuff surgery. These trials are investigator sponsored initiatives that Orgenesis will continue to support.

Productsin IND Enabling Studies

Weare engaged in the following IND-enabling studies:

Generationof Autologous Insulin-Producing Cells (AIPs) from Adult Liver Cells (“Trans-differentiation technology”)

OrgenesisLtd. has trans-differentiation in-vitro technology that has demonstrated in animal models the capacity to induce a shiftin the developmental fate of cells from the liver or other tissues, transdifferentiating them into “pancreatic beta cell-like”AIP cells for patients with Type 1 Diabetes (“T1D”), acute pancreatitis and other insulin deficient diseases. For the treatment of diabetes, cells are derived from the liveror other adult tissue and are trans-differentiated to become AIP cells. This technology, which has yet to be proven in human clinicaltrials, has shown in relevant animal models that the human derived AIP cells produce insulin in a glucose-sensitive manner. Noadverse effects were observed in any of the animal studies. This trans-differentiation technology is licensed by the Israeli Subsidiaryand is based on the work of Prof. Sarah Ferber, a researcher at Tel Hashomer Medical Research Infrastructure and Services Ltd.(“THM”) in Israel. The development plan calls for conducting additional pre-clinical safety and efficacy studies withrespect to diabetes and other potential indications prior to initiating human clinical trials.

Withrespect to the trans-differentiation technology, we have exclusive rights to seven (7) United States and twelve (12) foreign issuedpatents, five (5) pending patent applications in the United States, twenty four (24) pending patent applications in foreign jurisdictions,including, Australia, Brazil, Canada, China, Europe, India, Israel, Panama, South Korea, and Singapore. These patents and patentapplications relate, among others, to the trans-differentiation of cells (including hepatic cells) to cells having pancreaticβ-cell-like phenotype and function and to their use in the treatment of degenerative pancreatic disorders, including diabetes,pancreatic cancer and pancreatitis.

OnJune 11, 2019, the FDA granted Orphan Drug Designation for our AIP cells as a cell replacement therapy for the treatment of severehypoglycemia-prone diabetes resulting from total pancreatectomy (“TP”) due to chronic pancreatitis. The incidenceof diabetes following TP is 100%, resulting in immediate and lifelong insulin-dependence with the loss of both endogenous insulinsecretion and that of the counter-regulatory hormone, glucagon. Glycemic control after TP is notoriously difficult with conventionalinsulin therapy due to complete insulin dependence and loss of glucagon-dependent counter-regulation. Patients with this conditionexperience both severe hyperglycemic and hypoglycemic episodes.

OnApril 29, 2019, we received Institutional Review Board (“IRB”) approval to collect liver biopsies from patients atRambam Medical Center located in Haifa, Israel for a planned study to confirm the suitability of liver cells for personalizedcell replacement therapy for patients with insulin-dependent diabetes resulting from total or partial pancreatectomy. The firstpatients were enrolled during 2020. The goal of the proposed study, entitled “Collection of Human Liver Biopsy and WholeBlood Samples from Type 1 Diabetes Mellitus (T1DM), Total or Partial Pancreatectomy Patients for Potential use as an AutologousSource for Insulin Producing Cells in Future Clinical Studies,” is to confirm the suitability of the liver cells for personalizedcell replacement therapy, as well as eligibility of patients to participate in a future clinical study, as defined by successfulAIP cell production from their own liver biopsy. The secondary objective of the study is to evaluate patients’ immune responseto AIPs based on the patient’s blood samples and followed by subcutaneous implantation into the patients’ arm whichwould represent the first human trial.

Thetrans-differentiation technology is from a licensing agreement entered into as of February 2, 2012 by the Israeli Subsidiary andTHM pursuant to which the Israeli Subsidiary, Orgenesis Ltd, was granted a worldwide royalty bearing and exclusive license (the“THM License Agreement”). By using therapeutic agents that efficiently convert a sub-population of liver cells intopancreatic islets phenotype and function, this approach allows the diabetic patient to be the donor of his own therapeutic tissue.While we believe that this provides a major competitive advantage to the cell transformation technology of the Israeli Subsidiary,we also believe that our expanded focus to other therapies and business activities may continue to prompt THM to inquire of suchactivities as they may relate to our compliance with the terms or direction in regards to the THM License Agreement. Whilewe have not received any notice of cancellation of the THM License Agreement, we have received an allegation regarding the scopeof the rights by THM that may present future challenges for our Israeli Subsidiary to continue to develop, manufacture, sell andmarket the products pursuant to the milestones and time schedule specified in the development plan of the THM License Agreement.

ORG-CAR19,Autologous CD-19 CAR-T

Chimericantigen receptor T cells (also known as CAR-T cells) are T cells that have been genetically engineered to produce an artificialT-cell receptor for use in immunotherapy. CAR-T cell therapy uses T cells engineered with CARs for cancer therapy. The premiseof CAR-T immunotherapy is to modify T cells to recognize cancer cells in order to more effectively target and destroy them. Physiciansharvest T cells from patients, genetically alter them, then infuse the resulting CAR-T cells into patients to attack their tumors.CAR-T cells can be either derived from T cells in a patient’s own blood (autologous) or derived from the T cells of anotherhealthy donor (allogeneic). Once isolated from a person, these T cells are genetically engineered to express a specific CAR, whichprograms them to target an antigen that is present on the surface of tumors. After CAR-T cells are infused into a patient, theyact as a “living drug” against cancer cells. When they come in contact with their targeted antigen on a cell, CAR-Tcells bind to it and become activated, then proceed to proliferate and become cytotoxic.

Weare developing a new and advanced anti-CD19 CAR-T therapy for treating B-cell Acute lymphoblastic leukemia (B-ALL) and lymphomapatients, based on a clinically used CAR-T therapy licensed from Kecellitics Biotech. B-ALL is driven by malignant B-cell, expressingthe B-cell surface protein, CD19. Orgenesis is also working on combining the CD19 with CD22 CAR on a single, bi-specific CD19/22CAR-T that can target both antigens simultaneously for the treatment of blood cancers.

DualCellular vaccine (DUVAC), Therapy for Pancreatic Cancer

The DUVAC cell-based immunotherapy,licensed from Columbia University, is based on autologous dendritic cells and macrophages. These cells are key coordinators ofthe innate and adaptive immune system and have critical roles in the induction of antitumor immunity. The cells are exposed towhole cancer cells constitute the most comprehensive source of cancer antigens and by so boosting the patient immune system anddirect it against the tumor. The DUVAC vaccine can be a developed for a wide range of solid tumor, but our initial focus ison pancreatic cancer.

MetabolicallyOptimized T-Cells (MOTC): Therapy for melanoma and lung cancer

Inthe early stages of cancer, some lymphocytes successfully attack and infiltrate the tumor microenvironment, surround the tumorcells, and mount an anti-tumor response. TIL therapy is a clinically validated personalized cancer treatment based on infusionof autologous TILs expanded ex vivo from tumors. Once expanded, the TILs are infused back into the patient where they attackthe cancer cells with a high degree of specificity. Orgenesis is developing an advanced cellular biomanufacturing platform integratedwith metabolic control. The expanded TILs possess an optimized metabolic state referred to as MOTC (Metabolically Optimized T-Cells),which can potentially lead to a more robust therapeutic response, especially for solid tumors such as lung cancer and melanoma.

Productsin Pre-Clinical Studies

CAR-NK,Therapy for Solid Tumors

Wehave licensed from Caerus Therapeutics (a related party) a unique CAR platform that contains additional immunological effectorsthat aim to address significant challenges emerged in the development process of CAR technologies such as: safety, viability,immunosuppression by tumor microenvironment and dense desmoplastic stroma. Orgenesis aims target this CAR platform Natural KillerCells (CAR-NK) platform for the treatment of solid tumors.

AutologousCell-Based Vaccine for protecting against SARS-CoV-2

Weare working on developing a cell-based vaccine platform for the prevention of viral diseases. The initial target for the platformis SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the causative agent of COVID-19). This cell-based vaccine platformutilizes an autologous approach. The goal is to enable the COVID-19 engineered cells will have the ability to activate an endogenousimmune response and induce the production of neutralizing antibodies as well as cellular response.

Bioxomes

Exosomesare small, membrane-enclosed extracellular vesicles implicated in cell-to-cell communication. Exosomes may serve as a valuabletherapeutic modality because of their ability to transfer a wide variety of therapeutic payloads among cells that can influencea cell in multiple ways, and they can be designed to reach specific cell types. We are developing a proprietary manufacturingprocess for exosome like structures, termed Bioxomes. Bioxomes can carry specific therapeutic cargo into target cells. Orgenesisis developing this platform technology to treat liver fibrosis, dermatology, and other indications.

MSCP

Orgenesisis developing a personalized cell-based therapy product for wound healing and psoriasis. The product is based on Adipose-DerivedStem Cells (ADSCs). Following expansion, the ADSCs are formulated with Topiramate, a well-known substrate used in other indications,and a commercially available hyaluronic acid (HA), a well-known dermal filler, for topical treatment.

Muscle-derivedMesenchymal Stem Cells for Human Regenerative Medicine

Aninnovative and patented technology licensed by Revatis that enables the isolation of pluripotent adult Mesenchymal Stem Cells(MSCs) from a minimally invasive muscle micro-biopsy. The isolated autologously undifferentiated muscle-derived MSCs are developedto explore autologous therapeutics fields in humans such as Urine Incontinence

KidneyDisease

Weare also developing multiple Proprietary cell and cell derived products therapies for treating kidney failure and End-Stage RenalDisease (ESRD).

KT-DM-103and KT-CP-203 (3D-Printed Pancreatic Islets)

Koligohad exclusively licensed patents and technology from the University of Louisville Research Foundation related to the revascularizationand 3D printing of cell and tissue for transplant (“3D-V” technology platform). Orgenesis is developing this technologyfor potential autologous and allogeneic pancreatic islet transplant to treat type 1 diabetes (KT-DM-103) and chronic pancreatitis(KT-CP-203). The 3D-V technology platform may also support improved transplantation of other cell and tissue types in additionalto pancreatic islets.

POCarePlatform Strategy

Ouraim is to provide a pathway to bring ATMPs in the cell and gene therapy industry from research to patients worldwide through ourPOCare Platform. We define point of care as a process of collecting, processing, and administering cells within the patient careenvironment, namely through academic partnerships in a hospital setting. We believe that this approach is an attractive propositionfor personalized medicine because of our strategic partnerships with suppliers that help us to customize closed systems into effectivemobile clean room facilities. This will potentially help to minimize or eliminate the need for cell transportation, which is ahigh-risk and costly aspect of the supply chain.

Weaim to build value in various aspects of our company ranging from supply related processes including development and distributionsystems, clinical and regulatory services, engineering and devices such as OMPULs discussed below, delivery systems, therapiesincluding immuno-oncology, anti-aging, anti-viral, metabolic, nephrology, dermatology, orthopedic, as well as regenerative technologies.

Overtime, we have worked to develop and validate POCare Technologies that can be combined within mobile production units for advancedtherapies. In 2020, we made significant investments in the development of several types of Orgenesis Mobile ProcessingUnits and Labs (OMPULs) with the expectation of use and/or distribution through our POCare Network of partners, collaborators,and joint ventures.

In2020 we made significant investments in the development of several types of OMPULs and have made significant progress in the validation,risk analysis, regulatory and other related tasks relating to the OMPULS. We anticipate distributing and using the OMPULS throughour POCare Network of partners, collaborators, and joint ventures. OMPULs are designed for the purpose of validation, development,performance of clinical trials, manufacturing and/or processing of potential or approved cell and gene therapy products in a safe,reliable, and cost-effective manner at the point of care, as well as the manufacturing of such CGTs in a consistent and standardizedmanner in all locations. The design delivers a potential industrial solution for us to deliver CGTs to most clinical institutionsat the point of care.

*Forillustrative purposes only

Currently,we are finalizing the development over 30 OMPUL-based POC processing locations worldwide and, with the assistance of our partners,we are adapting the local requirements of each partner with the target of achieving a capacity to process and supply CGTs to asmany as 2,000 patients annually. The responsibility for setting up the OMPULS falls on the joint venture partners, who are alsoresponsible for marketing and distribution worldwide. As we expand operations, the OMPUL setup cost is expected to decline proportionately.Most of our POC revenue to date is in support of the implementation of our technologies and therapies in our partners’ POCactivities, which will be the basis for future royalties and supply revenues.

Wehave embarked on a strategy of collaborative arrangements with strategically situated regional joint venture partners around theworld. We believe that these parties have the expertise, experience and strategic location to advance our POCare Platform.

StrategicCGT Therapeutics Collaborations

Collaborations,partnerships, joint ventures and license agreements are a key component of our POC strategy.

Our POC technology collaboratorsand partners include Mircod, , Cure Therapeutics, Columbia University in the City of New York, Caerus Therapeutics Corporation,Sescom Ltd., UC Davis, SBH Sciences, Inc., The Johns Hopkins University and others.

Inaddition, we have collaborations and joint ventures for setting up POCare Platform operations facilities in jurisdictions throughoutthe world, including various countries in North America, Europe, Latin America, Asia, the Middle East, and Australia.

Formore information, see Note 11, “Collaboration and Licensing Agreements” of the “Notes to the Financial Statements”included in Item 8.

CDMOBusiness

Regardingthe Masthercell Sale, see Note 3 to Item 8 of this Annual Report.

CurrentDevelopment Facilities

OBI

OBIis a specialized process and technology development wholly owned subsidiary focused on custom-made process development, upscalingdesign from lab to industry innovation and automation procedures, which are extremely essential in the cell therapy industry.OBI is located in Bar-Lev Industrial Park utilizing the exclusive Israeli innovative ecosystem and highly experienced and talentedassociates including Ph.D. holders and biotechnology engineers. The center provides end to end solutions to cell therapy industrialization,process development capabilities and proficiency, custom-made engineering and a unique platform for creative design and processoptimization. OBI occupies 1300 square meters of labs and offices resulting in an efficient and unique environment for cell therapydevelopment. In connection with the Masthercell Sale, for a period of 3 years in the European Union and five years in the UnitedStates and the rest of the world from the closing date of the Masthercell Sale, we agreed that OBI will not manufactureproducts on a contract basis for third-party customers in any jurisdiction other than the State of Israel, but it mayconduct such CDMO business in the State of Israel, solely for customers located within the State of Israel or with respect totherapies intended for distribution solely within the State of Israel.

TheKorean Subsidiary

TheKorean Subsidiary has a particular focus on developing innovative cell therapies. Together, with promising in-house research programs,the technologies are currently under development for the rapidly growing Korean market offering the most favorable environmentfor the cell therapy industry in the world. Through close collaboration with leading medical and academic facilities, the KoreanSubsidiary is accelerating the development of foreign technologies in Korea. In connection with the Masthercell Sale, for a periodof 3 years in the European Union and five years in the United States and the rest of the world from the closing date of the MasthercellSale, we agreed that the Korean Subsidiary will not manufacture cell and gene products on a contract basis for third-partycustomers in any jurisdiction other than South Korea, but it may conduct CDMO business in South Korea, solely for customerslocated within South Korea and with respect to therapies intended for distribution solely within South Korea.

Koligo

Koligomaintains commercial production facilities for KYSLECEL at an FDA-registered establishment in Indiana. The Tissue Genesis Icellators,and associated reagents and kits, are made by contract manufacturers and warehoused at our facility in Texas. Koligo also maintainsdevelopment labs at the Indiana and Texas locations to support continued development.

TheBelgian subsidiary

TheBelgian subsidiary specializes in developing and validating proprietary and licensed advanced cell and gene therapies. The subsidiarybenefits both from its central position in Europe and its being in the leading Walloon biotech cluster. Located near Namur, atNovalis Science Park, the Belgian subsidiary collaborates with leading medical and academic facilities which enables it to coverthe drug product life cycle from research to clinical stage through pre-clinical and quality control. It occupies innovativefacilities for the development and quality control of therapies in R&D and GMP grades.

Itstalented and highly experienced staff and collaborators, including Ph.D. holders, quality assurance experts and biotechnologymanufacturing engineers, contribute to the POCare platform development and roll-out. The subsidiary provides quality assuranceand supply activities for the global POCare network. It has developed smart and agile methodologies to ensure compliant and harmonizeddecentralization operations at POCare.

Notable2020 Activities

OnApril 7, 2020, we entered into an Asset Purchase Agreement (the “Tamir Purchase Agreement”) with Tamir Biotechnology,Inc. (“Tamir” or “Seller”), pursuant to which we agreed to acquire certain assets and liabilities of Tamirrelated to the discovery, development and testing of therapeutic products for the treatment of diseases and conditions in humans,including all rights to ranpirnase and use for antiviral therapy (collectively, the “Purchased Assets and Assumed Liabilities”and such acquisition, the “Tamir Transaction”). The Tamir Transaction closed on April 23, 2020. We paid $2.5 millionin cash and issued an aggregate of 3,400,000 shares (the “Shares”) of our common stock to Tamir resulting in a totalconsideration of $20.2 million. In November 2020, we filed a registration statement on Form S-3 to register the resale of theShares as required by the Tamir Purchase Agreement.

OnSeptember 26, 2020, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) withOrgenesis Merger Sub, Inc., a Delaware corporation and our wholly-owned subsidiary (“Merger Sub”), Koligo TherapeuticsInc., a Kentucky corporation (“Koligo”), the shareholders of Koligo (collectively, the “Shareholders”)and Long Hill Capital V, LLC, solely in its capacity as the representative, agent and attorney-in-fact of the Shareholders. TheMerger Agreement provided for the acquisition of Koligo by us through the merger of Merger Sub with and into Koligo, with Koligosurviving as our wholly-owned subsidiary (the “Merger”). The Merger closed on October 15, 2020.

Koligo’soperations include (a) the manufacture and sale of KYSLECEL® (autologous pancreatic islets) for chronic and acute recurrentpancreatitis diseases in the United States; (b) development and commercialization of the Tissue Genesis Icellator® platform,a cell isolation system acquired by Koligo from Tissue Genesis, LLC prior to our acquisition of Koligo; and (c) preclinical developmentof the “3D-V” technology platform, a system exclusively licensed by Koligo from the University of Louisville ResearchFoundation intended for the revascularization and 3D printing of cell and tissue for transplant applications. Koligo maintainsfacilities in Indiana and Texas.

TheTissue Genesis assets acquired by Koligo included the entire inventory of Tissue Genesis Icellator® devices, related kitsand reagents, a broad patent portfolio to protect the technology, registered trademarks, clinical data, and existing businessrelationships for commercial and development stage use of the Icellator technology

Pursuantto the terms of the Merger Agreement, an aggregate of 2,061,713 shares of our common stock were issued to Koligo’s Shareholderswho were accredited investors (with certain Shareholders who were not accredited investors being paid solely in cash in the amountof approximately $20 thousand) in accordance with the terms of the Merger Agreement. In connection with the Merger, we assumedan aggregate of approximately $1.9 million of Koligo’s liabilities, which were substantially all of Koligo’s liabilitiesat the closing of the Merger. In addition, we issued 66,910 shares to Maxim Group LLC for advisory services in connection withthe Merger. In November 2020, we filed a registration statement on Form S-3 to register the resale of 1,425,962 shares ofour common stock as required by the Merger Agreement.

Inaddition, according to the agreement between the parties, we also funded an additional cash consideration of $500 thousand (with$100 thousand of such reducing the ultimate consideration payable to Koligo) for the acquisition of the assets of Tissue Genesis,LLC (“Tissue Genesis”) by Koligo that was consummated on October 14, 2020. The Tissue Genesis assets include the entireinventory of Tissue Genesis Icellator® devices, related kits and reagents, a broad patent portfolio to protect the technology,registered trademarks, clinical data, and existing business relationships for commercial and development stage use of the Icellatortechnology. The Icellator device is already commercially available in Korea and the Bahamas, and is expected to gain regulatoryapproval in Japan during the first quarter of 2021, subject to completion of manufacturing tests requested by the Japanese Pharmaceuticsand Medical Devices Agency. Tissue Genesis already initiated U.S. FDA IDE Phase 1 pilot trials SVF cells in the treatment of erectiledysfunction, critical limb ischemia, tissue repair, and other therapeutic indications.

RevenueModel, Business Development and Licenses

TheOrgenesis Point of Care (POCare) Platform is comprised of three enabling components: a multitude of licensed cell based POCareTherapeutics that are produced in closed, automated POCare Technology systems across a collaborative POCare Network. Ourtherapies include, but are not limited to, autologous, cell-based immunotherapies, therapeutics for metabolic diseases, anti-viraldiseases, and tissue regeneration. We are establishing and positioning the business to bring point-of-care therapies to patientsin a scalable way working directly with hospitals and through regional JV partners and JVs active in autologous cell therapy productdevelopment, including facilities in various countries in North America, Europe, Latin America, Asia, the Middle East, and Australia.The POCare Platform’s goal is to enable a rapid, globally harmonized pathway for these therapies to reach large numbersof patients at lowered costs through efficient, and decentralized production. The Network brings together industry partners, researchinstitutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies.

Weare focused on technology in licensing and therapeutic collaborations, and we out license therapies marketing rights and manufacturingrights to partners and / or to the JVs. In many cases, the JVs are responsible for the preparation of clinical trials, local regulatoryapprovals and regional marketing activities. Such licensing includes exclusive or nonexclusive, sublicensable, royalty bearingrights and license to the Orgenesis Background IP as required solely to manufacture, distribute and market and sell OrgenesisProducts within the relevant territories. In consideration of the rights and the licenses so granted, we receive a royaltyin the range of ten percent of the net sales generated by the JV Entity and/or its sublicensees (as applicable) with respect tothe Orgenesis Products.

Inaddition, in many cases, once the JV entities become profitable, we are entitled (in addition to any of its rights as holderof the JV Entity and prior to any other distributions of dividends by the JV Entity to shareholders of the JV Entity) and in additionto any royalties to which we may be entitled pursuant to a Orgenesis License Agreement, to receive from the JV entity royaltiesat a range of 10 to 15 percent of the JV entity’s audited US GAAP profit after tax.

Furtherto revenues generated from out licenses we generate revenues from POCare services and sales which is comprised of:

●	R&D services provided to out licensing partners

TheCompany has signed POCare Master Services Agreements (“MSAs”) with its JV partners. In terms of the MSAs, we providecertain broadly defined development services that relate to our licensed therapies designed to develop or enhance the therapywith the objective of preparing it for clinical use. Such services, per therapy, include regulatory services, pre-clinical studies,intellectual property services, development services, and GMP process translation.

●	Hospital supply

Hospitalservices includes the sale or lease of products and the performance of processing services to our POCare hospitals or other medicalproviders. We either work directly with hospitals or receive payments through our regional JV partnerships.

●	Cell process development revenue

Weprovide cell process development services in some regions to third party customers. Those services are unique to the customerswho retain the ownership of the intellectual property created through the process.

OurPOCare therapy revenue is as follows:

		Year Ended December 31,
Revenue stream:		2020				2019
		(in thousands)
POC and hospital services		$	6,068			$	3,109
Cell process development services			1,584				790
Total		$	7,652			$	3,899

Costof Research and Development and Research and Development Services

Weincurred $83,986 and $14,014 thousand in cost of sales, research and development and research and development services in thefiscal years ended December 31, 2020 and December 31, 2019, respectively, of which $196 and $812 thousand was covered by grantfunding. Part of the expense was funded by share issues. Our research and development scope was expanded to the evaluation anddevelopment of new cell therapies related technologies in the field of immuno-oncology, liver pathologies and tissue regeneration.

Competitionin the Cell Therapy Field

Thebiopharmaceutical industry is intensely competitive. There is continuous demand for innovation and speed, and as the cell-basedtherapies market evolves, there is always the risk that a competitor may be able to develop other compounds or drugs that areable to achieve similar or better results for indications. Potential competition includes major multinational pharmaceutical companies,established biotechnology companies, specialty pharmaceutical companies, universities, and other research institutions. Many ofthese competitors have substantially greater financial, technical, and other resources, such as larger research and developmentstaff and experienced marketing and manufacturing organizations with established sales forces. Smaller or early-stage companiesmay also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

Currently,we are not aware of any other companies pursuing a business model similar to what we are developing under our POCare Platform.However, our competitors in the CGT field who are significantly larger and better capitalized than us could undertake strategiessimilar to what we are pursuing and even develop them at a much more rapid rate. These potential competitors include the samemultinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities,and other research institutions that are operating in the CGT field. In that respect, smaller or early-stage companies may alsoprove to be significant competitors, particularly through collaborative arrangements with large, established companies.

IntellectualProperty

Wewill be able to protect our technology and products from unauthorized use by third parties only to the extent it is covered byvalid and enforceable claims of our patents or is effectively maintained as trade secrets. Patents and other proprietary rightsare thus an essential element of our business.

Oursuccess will depend in part on our ability to obtain and maintain proprietary protection for our product candidates, technology,and know-how, to operate without infringing on the proprietary rights of others, and to prevent others from infringing our proprietaryrights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applicationsrelated to our proprietary technology, inventions, and improvements that are important to the development of our business. Wealso rely on trade secrets, know-how, continuing technological innovation, and in-licensing opportunities to develop and maintainour proprietary position.

In addition, we own orhave exclusive rights to twenty eight (28) United States patents, thirty six (36) foreign-issued patents, twenty five (25) pendingpatent applications in the United States, forty five (45) pending patent applications in foreign jurisdictions, including Australia,Brazil, Canada, China, Europe, Hong Kong, India, Israel, Japan, Mexico, New Zealand, North Korea, Russia, Singapore, South Africa,and South Korea, and two (2) international Patent Cooperation Treaty (“PCT”) patent applications. These patents andpatent applications relate, among others, to (1) dendritic and macrophages based vaccines, and their use for treating cancer andviral diseases; (2) compositions comprising ranpirnase and other ribonucleases for treating viral diseases; (3)tumor infiltrating lymphocytes (TILs) and their use for treating cancer; (4) compositions comprising immune cells, ribonucleases,or antibodies for treating COVID-19; (5) whole-cell antiviral vaccines; (6) therapeutic compositions comprisingexosomes, bioxomes, and redoxomes; (7) bioreactors for cell cultureand automated devices for supporting cell therapies:and (8) scaffolds, including alginate and sulfated alginate scaffolds, polysaccharides thereof, and scaffolds for use for cellpropagation, transplantations, and in the treatment of autoimmune diseases.

Wehave a pending U.S. patent applications directed, among others, to dendritic and macrophages based vaccines, and their use fortreating cancer and viral diseases. If issued, this application would expire in 2038.

Wehave pending U.S. patent applications directed, among others, to compositions comprising ranpirnase and other ribonucleases fortreating viral diseases. If issued, these applications would expire between 2039 and 2040. Counterpart patents applications werefiled in Australia, Canada, China, Europe, Hong Kong, Japan, Mexico, New Zealand, North Korea, Russian Federation, Singapore,South Africa, and were also filed as International (“PCT”) applications. If issued, these applications would expirebetween 2035 and 2037. These expiration dates do not include any patent term extensions that might be available following thegrant of marketing authorizations.

Wehave pending U.S. patent applications directed, among others, to therapeutic compositions comprising exosomes, bioxomes, and redoxomes.If issued, these applications would expire in 2040. Counterpart patents applications were filed in Australia, Brazil, Canada,China, Europe, India, Israel, India, Japan and South Korea. If issued, these applications would expire in 2039. These expirationdates do not include any patent term extensions that might be available following the grant of marketing authorizations.

Wehave pending U.S. patent applications directed, among others, to automated devices for supporting cell therapies. If issued, theseapplications would expire between 2035 and 2038.

Wehave a pending U.S. provisional patent application directed, among others, to tumor infiltrating lymphocytes (TILs) and theiruse for treating cancer. If converted into a non-provisional application and issued, this application would expire in 2041, withoutincluding any patent term extensions that might be available following the grant of marketing authorizations.

We have pending U.S. provisional patent applications directed, amongothers, to compositions comprising immune cells, ribonucleases, or antibodies for treating COVID-19. If converted into a non-provisionalapplication and issued, this application would expire in 2041, without including any patent term extensions that might be availablefollowing the grant of marketing authorizations.

GrantedU.S. patents, which are directed among others to scaffolds, including alginate and sulfated alginate scaffolds, polysaccharidesthereof, and scaffolds for use for cell propagation, transplantations, and in the treatment of autoimmune diseases, will expirebetween 2025 and 2036. Counterpart patents granted in Australia, France, Germany, Israel, Switzerland, and the United Kingdom,will expire between 2026 and 2035. These expiration dates do not include any patent term extensions that might be available followingthe grant of marketing authorizations.

We have pending U.S.patent applications directed, among others, to bioconjugates comprising sulfated polysaccharides and diverse bioactive peptides,and their use in the treatment of inflammatory conditions. If issued, these applications would expire in 2038. Counterpart patentsapplications were filed in China, Europe, Israel, Japan, and South Korea. If issued, these applications would expire between 2026and 2038. These expiration dates do not include any patent term extensions that might be available following the grant of marketingauthorizations

OrgenesisLtd, has exclusive rights to six (6) United States patents, fourteen (14) foreign-issued patents, five (5) pending patent applicationsin the United States, twenty six (26) pending patent applications in foreign jurisdictions, including Australia, Brazil, Canada,China, Europe, India, Israel, Japan, Mexico, Panama, Singapore, and South Korea. These patents and patent applications relate,among others, to the trans-differentiation of cells (including hepatic cells) to cells having pancreatic β-cell-like phenotypeand function and to their use in the treatment of degenerative pancreatic disorders, including diabetes, pancreatic cancer andpancreatitis. Granted U.S. patents, which are directed among others to trans-differentiation to pancreatic β-cell-like phenotypeand function cells and to their use in the treatment of degenerative pancreatic disorders, including diabetes, pancreatic cancerand pancreatitis, will expire between 2024 and 2035. Counterpart patents granted in Australia, France, Germany, Israel, Switzerland,and the United Kingdom, will expire between 2024 and 2035. These expiration dates do not include any patent term extensions thatmight be available following the grant of marketing authorizations.

OrgenesisLtd, has pending U.S. patent applications directed, among others, to the trans-differentiation of cells, to cells having pancreaticβ-cell-like phenotype and function and to their use in the treatment of degenerative pancreatic disorders, including diabetes,pancreatic cancer and pancreatitis. If issued, these applications would expire between 2038 and 2040. Counterpart patents applicationswere filed in Australia, Brazil, Canada, China, Europe, India, Israel, Mexico, Panama, Singapore, South Korea, and were also filedas International (“PCT”) applications. If issued, these applications would expire between 2034 and 2039. These expirationdates do not include any patent term extensions that might be available following the grant of marketing authorizations.

GovernmentRegulation

DevelopmentBusiness

Weare required to comply with the regulatory requirements of various local, state, national and international regulatory bodieshaving jurisdiction in the countries or localities where we manufacture products or where our customers’ products are distributed.In particular, we are subject to laws and regulations concerning research and development, testing, manufacturing processes, equipmentand facilities, including compliance with cGMPs, labeling and distribution, import and export, facility registration or licensing,and product registration and listing. As a result, our facilities are subject to regulation in Israel and South Korea. We arealso required to comply with environmental, health and safety laws and regulations, as discussed below. These regulatory requirementsimpact many aspects of our operations, including manufacturing, developing, labeling, packaging, storage, distribution, importand export and record keeping related to customers’ products. Noncompliance with any applicable regulatory requirementscan result in government refusal to approve facilities for manufacturing products or products for commercialization.

Ourcustomers’ products must undergo pre-clinical and clinical evaluations relating to product safety and efficacy before theyare approved as commercial therapeutic products. The regulatory authorities that have jurisdiction in the countries in which ourcustomers intend to market their products may delay or put on hold clinical trials, delay approval of a product or determine thatthe product is not approvable. The regulatory agencies can delay approval of a drug if our manufacturing facilities are not ableto demonstrate compliance with cGTPs, pass other aspects of pre-approval inspections (i.e., compliance with filed submissions)or properly scale up to produce commercial supplies. The government authorities having jurisdiction in the countries in whichour customers intend to market their products have the authority to withdraw product approval or suspend manufacture if thereare significant problems with raw materials or supplies, quality control and assurance or the product is deemed adulterated ormisbranded. In addition, if new legislation or regulations are enacted or existing legislation or regulations are amended or areinterpreted or enforced differently, we may be required to obtain additional approvals or operate according to different manufacturingor operating standards or pay additional fees. This may require a change in our manufacturing techniques or additional capitalinvestments in our facilities.

Certainproducts manufactured by us involve the use, storage and transportation of toxic and hazardous materials. Our operations are subjectto extensive laws and regulations relating to the storage, handling, emission, transportation and discharge of materials intothe environment and the maintenance of safe working conditions. We maintain environmental and industrial safety and health complianceprograms and training at our facilities.

Prevailinglegislation tends to hold companies primarily responsible for the proper disposal of their waste even after transfer to thirdparty waste disposal facilities. Other future developments, such as increasingly strict environmental, health and safety lawsand regulations, and enforcement policies, could result in substantial costs and liabilities to us and could subject the handling,manufacture, use, reuse or disposal of substances or pollutants at our facilities to more rigorous scrutiny than at present.

Ourdevelopment operations involve the controlled use of hazardous materials and chemicals. Although we believe that our proceduresfor using, handling, storing and disposing of these materials comply with legally prescribed standards, we may incur significantadditional costs to comply with applicable laws in the future. Also, even if we are in compliance with applicable laws, we cannotcompletely eliminate the risk of contamination or injury resulting from hazardous materials or chemicals. As a result of any suchcontamination or injury, we may incur liability or local, city, state or federal authorities may curtail the use of these materialsand interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines,and the liability could exceed our resources. Compliance with applicable environmental laws and regulations is expensive, andcurrent or future environmental regulations may impair our contract manufacturing operations, which could materially harm ourbusiness, financial condition and results of operations.

Thecosts associated with complying with the various applicable local, state, national and international regulations could be significantand the failure to comply with such legal requirements could have an adverse effect on our results of operations and financialcondition. See “Risk Factors — Risks Related to Development and Regulatory Approval of Our Therapies and Product Candidates— Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially ourproduct development, manufacturing and distribution capabilities.” for additional discussion of the costs associated withcomplying with the various regulations.

POCareTherapies Portfolio

Ourtherapeutic portfolio pipeline is diverse and addresses various unmet clinical needs. It is predominantly comprised of novel autologouscell therapies, implying that patients receive cells that originate from their own body, virtually eliminating the risk of animmune response and rejection and thus easing various regulatory hurdles. In addition, by leveraging Orgenesis’ vast experienceand proven track record in developing and optimizing cell processing, these selective therapies are adapted to be produced inclosed, automated technology systems, reducing the need for high grade cleanroom environments. The systems enable each stage ofthe manufacturing process (cell sorting, expansion, genetic modifications, quality control) to be optimized in order to substantiallyreduce the cost burden for patients and making the therapies widely accessible. Notably, our therapeutic pipeline is developedby researchers from our network and are subsequently outlicensed and validated in multi-center clinical trials conducted acrosspoint of care partner sites leveraging the robustness of the Orgenesis network. Once approved these therapies are distributedto leading medical institutions globally within the our network and thus granting the inventors a royalty-based commercializationhorizon.

RegulatoryProcess in the United States

Ourpotential product candidates are subject to regulation as a biological product under the Public Health Service Act and the Food,Drug and Cosmetic Act. The FDA generally requires the following steps for pre-market approval or licensure of a new biologicalproduct:

●

Pre-clinical laboratory and animal tests conducted in compliance with the Good Laboratory Practice, or GLP, requirements to assess a drug’s biological activity and to identify potential safety problems, and to characterize and document the product’s chemistry, manufacturing controls, formulation, and stability;

●	Submission to the FDA of an Investigational New Drug, or IND, application, which must become effective before clinical testing in humans can start;
●	Obtaining approval of Institutional Review Boards, or IRBs, of research institutions or other clinical sites to introduce a first human biologic drug candidate into humans in clinical trials;
●	Conducting adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for its intended indication conducted in compliance with Good Clinical Practice, or GCP, requirements;
●	Compliance with current Good Manufacturing Practices (“cGMP”) regulations and standards;
●	Submission to the FDA of a Biologics License Application (“BLA”) for marketing that includes adequate results of pre-clinical testing and clinical trials;
●	The FDA reviews the marketing application in order to determine, among other things, whether the product is safe, effective and potent for its intended uses; and
●	Obtaining FDA approval of the BLA, including inspection and approval of the product manufacturing facility as compliant with cGMP requirements, prior to any commercial sale or shipment of the pharmaceutical agent. The FDA may also require post marketing testing and surveillance of approved products or place other conditions on the approvals.

RegulatoryProcess in Europe

TheEuropean Union (“EU”) has approved a regulation specific to cell and tissue therapy products, the Advanced TherapyMedicinal Product (“ATMP”) regulation. For products that are regulated as an ATMP, the EU directive requires:

●	Compliance with current cGMP regulations and standards, pre-clinical laboratory and animal testing;
●	Filing a Clinical Trial Application (“CTA”) with the various member states or a centralized procedure;
●	Voluntary Harmonization Procedure (“VHP”), a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries;
●	Obtaining approval of ethic committees of research institutions or other clinical sites to introduce the AIP into humans in clinical trials;
●	Adequate and well-controlled clinical trials to establish the safety and efficacy of the product for its intended use;
●	Submission to EMEA for a Marketing Authorization (“MA”); and
●	Review and approval of the MAA (“Marketing Authorization Application”).

Asin the U.S., prior to the general regulatory process of a new biologic products, we will prosecute an Orphan Drug Designationfor treatment of Patients with Established Diabetes Mellitus (“DM”) Induced by Total pancreatectomy. In the EU, inorder to be qualified, the prevalence must be below 5 per 10,000 of the EU population, except where the expected return on investmentis insufficient to justify the investment.

Authorizedorphan medicines benefit from 10 years of protection from market competition with similar medicines with similar indications oncethey are approved. Companies applying for designated orphan medicines pay reduced fees for regulatory activities. This includesreduced fees for protocol assistance, marketing-authorization applications, inspections before authorization, applications forchanges to marketing authorizations made after approval, and reduced annual fees.

ClinicalTrials

Typically,both in the U.S. and the EU, clinical testing involves a three-phase process, although the phases may overlap. In Phase I, clinicaltrials are conducted with a small number of healthy volunteers or patients and are designed to provide information about productsafety and to evaluate the pattern of drug distribution and metabolism within the body. In Phase II, clinical trials are conductedwith groups of patients afflicted with a specific disease in order to determine preliminary efficacy, optimal dosages and expandedevidence of safety. In some cases, an initial trial is conducted in diseased patients to assess both preliminary efficacy andpreliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II trial. PhaseIII clinical trials are generally large-scale, multi-center, comparative trials conducted with patients afflicted with a targetdisease in order to provide statistically valid proof of efficacy, as well as safety and potency. In some circumstances, the FDAor EMA may require Phase IV or post-marketing trials if it feels that additional information needs to be collected about the drugafter it is on the market. During all phases of clinical development, regulatory agencies require extensive monitoring and auditingof all clinical activities, clinical data, as well as clinical trial investigators. An agency may, at its discretion, re-evaluate,alter, suspend, or terminate the testing based upon the data that have been accumulated to that point and its assessment of therisk/benefit ratio to the patient. Monitoring all aspects of the study to minimize risks is a continuing process. All adverseevents must be reported to the FDA or EMA.

TheFDA has granted Orphan Drug designation for our AIP cells as a cell replacement therapy for the treatment of severe hypoglycemia-pronediabetes resulting from TP due to chronic pancreatitis. The FDA’s Orphan Drug Designation Program provides orphan statusto drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rarediseases/disorders that affect fewer than 200,000 people in the United States. Orphan designation qualifies the sponsor of thedrug for various development incentives, including eligibility for seven years of market exclusivity upon regulatory approval,exemption from FDA application fees, tax credits for qualified clinical trials, and other potential assistance in the drug developmentprocess .

Employees

Asof December 31, 2020, we had an aggregate of 111 employees working at our company and subsidiaries. In addition, we retain theservices of outside consultants for various functions including clinical work, finance, accounting and business development services.Most of our senior management and professional employees have had prior experience in pharmaceutical or biotechnology companies.None of our employees are covered by collective bargaining agreements. We believe that we have good relations with our employees.

Corporateand Available Information

OurAnnual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and all amendments to those reports areavailable free of charge though our website ( http://www.orgenesis.com ) as soon as practicable after such material is electronicallyfiled with, or furnished to, the Securities and Exchange Commission (the “SEC”). Except as otherwise stated in thesedocuments, the information contained on our website or available by hyperlink from our website is not incorporated by referenceinto this report or any other documents we file, with or furnish to, the SEC.

Ourcommon stock is listed and traded on the Nasdaq Capital Market under the symbol “ORGS.”

Asused in this Annual Report on Form 10-K and unless otherwise indicated, the term “Company” refers to Orgenesis Inc.and its Subsidiaries. Unless otherwise specified, all amounts are expressed in United States Dollars.

ITEM1A. RISK FACTORS

Summaryof Risk Factors

Belowis a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does notaddress all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risksthat we face, can be found below under the heading “Risk Factors” and should be carefully considered, together withother information in this Annual Report on Form 10-K and our other filings with the SEC, before making an investment decisionregarding our common stock.

●	The failure to effectively utilize the proceeds from the sale of Masthercell to scale our POC business to show demonstrable revenue may adversely affect our business.
●	Our research and development efforts on novel technology using cell-based therapy and our future success is highly dependent on the successful development of that technology.

●	We have entered into collaborations and may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
●	Our success will depend on strategic collaborations with third parties to develop and commercialize therapeutic product candidates, and we may not have control over a number of key elements relating to the development and commercialization of any such product candidate.
●	The coronavirus outbreak has the potential to cause disruptions in our business, including our clinical development activities.
●	Our success depends on our ability to protect our intellectual property and our proprietary technologies.
●	If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
●	We are increasingly dependent on information technology and our systems and infrastructure face certain risks, including cybersecurity and data storage risks.
●	There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, we may not be able to generate product revenue.
●	Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences.
●	Our product candidates are biologics and the manufacture of our product candidates is complex and we may encounter difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities.
●	Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products.
●	We currently have no marketing and sales organization and have no experience in marketing therapeutic products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.
●	There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, we may not be able to generate product revenue.
●	We face significant competition from other biotechnology and pharmaceutical companies, many of which have substantially greater financial, technical and other resources, and our operating results will suffer if we fail to compete effectively.
●	We are highly dependent on key personnel who would be difficult to replace, and our business plans will likely be harmed if we lose their services or cannot hire additional qualified personnel.
●	Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.
●	Third parties to whom we may license or transfer development and commercialization rights for products covered by intellectual property rights may not be successful in their efforts and, as a result, we may not receive future royalty or other milestone payments relating to those products or rights.

RiskFactors

Aninvestment in our common stock involves a number of very significant risks. You should carefully consider the following risksand uncertainties in addition to other information in this report in evaluating our company and its business before purchasingshares of our company’s common stock. Our business, operating results and financial condition could be seriously harmeddue to any of the following risks. You could lose all or part of your investment due to any of these risks.

RisksRelated to Our Company and POC Business

Wewill need to deploy our capital from the sale of Masthercell in a manner to scale our POC business to show demonstrable revenueand market value for our shareholders, the failure of which could adversely impact our operations and the price of our stock.

OnFebruary 2, 2020, we entered into a Stock Purchase Agreement (the “Purchase Agreement”) with GPP-II Masthercell LLC(“GPP” and together with Orgenesis, the “Sellers”), Masthercell Global Inc. (“Masthercell”)and Catalent Pharma Solutions, Inc. (the “Buyer”). Pursuant to the terms and conditions of the Purchase Agreement,on February 10, 2020, the Sellers sold 100% of the outstanding equity interests of Masthercell to Buyer (the “Sale”)for an aggregate nominal purchase price of $315 million, subject to customary adjustments. After accounting for GPP’s liquidationpreference and equity stake in Masthercell as well as SFPI - FPIM’s interest in MaSTherCell S.A., distributions to Masthercelloption holders and transaction costs, we received approximately $126.7 million at the closing of the Sale transaction, of which$7.2 million was used for the repayment of intercompany loans and payables.

Theproceeds from the sale of Masthercell were received by us and not our shareholders. We used or will use a portion of the proceedsto repay certain outstanding indebtedness and to pay for certain additional transaction costs associated with the sale. We willalso be paying taxes on the proceeds.

Weexpect to use the remainder of net proceeds from the sale of Masthercell, at the discretion of our Board of Directors, for workingcapital and other general corporate purposes, including to continue to grow our POC cell therapy business and to further the developmentof ATMPs. Although we now have sufficient capital resources for the next 12 months and the foreseeable future, we may not be ableto implement our POC business and commence clinical trials for our diabetes solution or respond to competitive pressures due toother non-financial factors beyond our control. Our failure to effectively utilize the proceeds from the sale of Masthercell couldadversely affect our ability to successfully grow our POC business and develop cell therapy product candidates, which could causethe value of your investment in Orgenesis to decline.

Weare not profitable as of December 31, 2020 , have limited cash flow and, unless we increase revenues and take advantage of any commercial opportunities that arise toexpand our POC business, the perceived value of our company may decrease and our stock price could be affected accordingly.

Forthe fiscal year ended December 31, 2020 and as of the date of this report, we assessed our financial condition and concluded thatwe have sufficient resources for the next 12 months from the date of the report as a result of the receipt of the net proceedsfrom the sale of Masthercell. Our auditor’s report for the year ended December 31, 2020 does not include a going concernopinion on the matter. However, management is unable to predict if and when we will be able to generate significant revenues orachieve profitability. Our plan regarding these matters is to continue improving the net results in our POC business into fiscalyear 2021. There can be no assurance that we will be successful in increasing revenues, improving our POC results or that theperceived value of our company will increase. In the event that we are unable to generate significant revenues in our POC business,our stock price could be adversely affected.

Ourresearch and development programs are based on novel technologies and are inherently risky.

Weare subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of ourcell therapy technology creates significant challenges with respect to product development and optimization, manufacturing, governmentregulation and approval, third-party reimbursement and market acceptance. For example, the FDA and EMA have relatively limitedexperience with the development and regulation of cell therapy products and, therefore, the pathway to marketing approval forour cell therapy product candidates may accordingly be more complex, lengthy and uncertain than for a more conventional productcandidate. The indications of use for which we choose to pursue development may have clinical effectiveness endpoints that havenot previously been reviewed or validated by the FDA or EMA, which may complicate or delay our effort to ultimately obtain FDAor EMA approval. Because this is a new approach to treating diseases, developing and commercializing our product candidates subjectsus to a number of challenges, including:

●	obtaining regulatory approval from the FDA, EMA and other regulatory authorities that have very limited experience with the commercial development of our technology for treating different diseases;
●	developing and deploying consistent and reliable processes for removing the cells from the patient engineering cells ex vivo and infusing the engineered cells back into the patient;
●	developing processes for the safe administration of these products, including long-term follow-up for all patients who receive our products;
●	sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our products;
●	developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on investment;
●	establishing sales and marketing capabilities after obtaining any regulatory approval to gain market acceptance; and
●	maintaining a system of post marketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process.

Ourefforts to overcome these challenges may not prove successful, and any product candidate we seek to develop may not be successfullydeveloped or commercialized.

Kyslecel may notachieve patient or market acceptance, which could have a material adverse effect on our business.

Ourcommercialization strategy for Kyslecel relies on medical specialists, medical facilities and patients adopting TP-IAT with Kyslecelas an accepted treatment for chronic pancreatitis. However, medical specialists are historically slow to adopt new treatments,regardless of perceived merits, when older treatments continue to be supported by established providers. Overcoming such resistanceoften requires significant marketing expenditure or definitive product performance and/or pricing superiority. The cost of allocatingresources for such requirements might severely impact the potential for profitability of Kyslecel.

Thereis no guarantee that physician or patient acceptance of TP-IAT with Kyslecel will be substantial. Further, there is no guaranteethat Koligo will be able to achieve patient acceptance or obtain enough customers (clinical providers) to meet its sales objectives.If we do not meet our sales objectives, our business prospects and financial performance will be materiallyand adversely affected.

Further,we are partially reliant on published clinical trials and scientific research conducted by third parties to justifythe patient benefit and safety of TP-IAT with Kyslecel and, as such, we rely, in part, on the accuracy and integrity ofthose third-parties to have reported the results and correctly collected and interpreted the data from all clinical trials conductedto date. If published data turn out to later be incorrect or incomplete, our business prospects and financial performancemay be materially and adversely affected.

The therapeutic efficacy of ranpirnase and our other product candidates is unproven in humans, and we may not be able to successfully develop and commercialize ranpirnase or any of our other product candidates.

Ranpirnaseand our other product candidates are novel compounds and their potential benefit as antiviral drugs or immunotherapies is unproven.Ranpirnase and our other product candidates may not prove to be effective against the indications for which they are being designedto act and may not demonstrate in clinical trials any or all of the pharmacological effects that have been observed in preclinicalstudies. As a result, our clinical trial results may not be indicative of the results of future clinical trials.

Ranpirnaseand our other product candidates may interact with human biological systems in unforeseen, ineffective or harmful ways. If ranpirnaseor any of our other product candidates is associated with undesirable side effects or have characteristics that are unexpected,we may need to abandon the development of such product candidate or limit development to certain uses or subpopulations in whichthe undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.Because of these and other risks described herein that are inherent in the development of novel therapeutic agents, we may neversuccessfully develop or commercialize ranpirnase or any of our other product candidates, in which case our business will be harmed.

Wewill need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.

Asof December 31, 2020, we had 111 employees. As our development and commercialization plans and strategies develop, we must adda significant number of additional managerial, operational, sales, marketing, financial, and other personnel. Future growth willimpose significant added responsibilities on members of management, including:

●	identifying, recruiting, integrating, maintaining, and motivating additional employees;
●	managing our internal development efforts effectively, including the clinical and FDA review process for our product candidates, while complying with our contractual obligations to contractors and other third parties; and
●	improving our operational, financial and management controls, reporting systems, and procedures.

Ourfuture financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectivelymanage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-dayactivities in order to devote a substantial amount of time to managing these growth activities. This lack of long-term experienceworking together may adversely impact our senior management team’s ability to effectively manage our business and growth.

Wecurrently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations,advisors and consultants to provide certain services. There can be no assurance that the services of these independent organizations,advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements.In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services providedby consultants is compromised for any reason, our clinical trials may be extended, delayed, or terminated, and we may not be ableto obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we willbe able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonableterms, if at all. If we are not able to effectively expand our organization by hiring new employees and expanding our groups ofconsultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercializeour product candidates and, accordingly, may not achieve our research, development, and commercialization goals.

Currencyexchange fluctuations may impact the results of our operations.

Theprovision of services by our former subsidiary, Masthercell Global, were usually transacted in U.S. dollars and European currenciesduring the year ended December 31, 2020. Our results of operations are affected by fluctuations in currency exchange rates inboth sourcing and selling locations. Our results of operations may still be impacted by foreign currency exchange rates, primarily,the euro-to-U.S. dollar exchange rate. In recent years, the euro-to-U.S. dollar exchange rate has been subject to substantialvolatility which may continue, particularly in light of recent political events regarding the European Union, or EU. Because wedo not hedge against all of our foreign currency exposure, our business will continue to be susceptible to foreign currency fluctuations.

Wehave entered into collaborations and may form or seek collaborations or strategic alliances or enter into additional licensingarrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

Wehave entered into collaborations and joint ventures and may form or seek strategic alliances, create joint ventures or collaborations,or enter into additional licensing arrangements with third parties that we believe will complement or augment our developmentand commercialization efforts with respect to our product candidates and any future product candidates that we may develop. Anyof these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures,issue securities that dilute our existing stockholders, or disrupt our management and business. In addition, we face significantcompetition in seeking appropriate strategic partners for which the negotiation process is time-consuming and complex. Moreover,we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our productcandidates because they may be deemed to be at too early of a stage of development for collaborative effort and third partiesmay not view our product candidates as having the requisite potential to demonstrate safety and efficacy. Further, collaborationsinvolving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous risks,which may include the following:

●	collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;
●	collaborators may not perform their obligations as expected;
●	collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;
●	collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing;
●	collaborators could fail to make timely regulatory submissions for a product candidate;
●	collaborators may not comply with all applicable regulatory requirements or may fail to report safety data in accordance with all applicable regulatory requirements;
●	collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
●	product candidates developed in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;
●	a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;
●	collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
●	disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;
●	collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and
●	collaborators may own or co-own intellectual property covering our products that results from our collaborating with them and, in such cases, we would not have the exclusive right to commercialize such intellectual property.

Asa result, if we enter into collaboration agreements and strategic partnerships or license our products or businesses, we may notbe able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operationsand company culture, which could delay our timelines or otherwise adversely affect our business. The success of our existing andfuture collaboration arrangements and strategic partnerships, which include research and development services by our collaboratorsto improve our intellectual property, will depend heavily on the efforts and activities of our collaborators and may not be successful.We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net incomethat justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related toour product candidates could delay the development and commercialization of our product candidates in certain geographies forcertain indications, which would harm our business prospects, financial condition, and results of operations.

Oursuccess will depend on strategic collaborations with third parties to develop and commercialize therapeutic product candidates,and we may not have control over a number of key elements relating to the development and commercialization of any such productcandidate.

Akey aspect of our strategy is to seek collaborations with partners, such as a large pharmaceutical organization, that are willingto further develop and commercialize a selected product candidate. To date, we have entered into a number of collaborative arrangementswith cell therapy organizations. By entering into any such strategic collaborations, we may rely on our partner for financialresources and for development, regulatory and commercialization expertise. Our partner may fail to develop or effectively commercializeour product candidate because they:

●	do not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as limited cash or human resources;
●	decide to pursue a competitive potential product developed outside of the collaboration;
●	cannot obtain the necessary regulatory approvals;
●	determine that the market opportunity is not attractive; or
●	cannot manufacture or obtain the necessary materials in sufficient quantities from multiple sources or at a reasonable cost.

Wemay not be able to enter into additional collaborations on acceptable terms, if at all. We face competition in our search forpartners from other organizations worldwide, many of whom are larger and are able to offer more attractive deals in terms of financialcommitments, contribution of human resources, or development, manufacturing, regulatory or commercial expertise and support. Ifwe are not successful in attracting a partner and entering into a collaboration on acceptable terms, we may not be able to completedevelopment of or commercialize any product candidate. In such event, our ability to generate revenues and achieve or sustainprofitability would be significantly hindered and we may not be able to continue operations as proposed, requiring us to modifyour business plan, curtail various aspects of our operations or cease operations.

Thecoronavirus outbreak has the potential to cause disruptions in our business, including our clinical development activities .

Theoutbreak of the novel strain of coronavirus, or COVID-19, has currently impacted and may continue to impact our business, includingour preclinical studies and clinical trials. COVID-19 has spread to multiple countries, including the United States and Israel,where we conduct most of our operations.

Effortsto contain the spread of COVID-19 have intensified and the United States and Israel, among other countries, have implemented andmay continue to implement severe travel restrictions, shelter in place orders, social distancing and delays or cancellations ofelective surgeries. These and other disruptions have caused, and may continue to cause, a delay in the supply of consumable goods,which could result in further delays, increased costs to source alternative suppliers and affect our ability to commercializeand develop our product candidates.

Thespread of an infectious disease, including COVID-19, may also result in a period of business disruption, and in reduced operations,including employee absenteeism and delays in payments from our customers, any of which could materially affect our business, financialcondition and results of operations. Although, as of the date of this Annual Report on Form 10-K, we do not expect any materialimpact on our long-term activity, the extent to which COVID-19 impacts our business will depend on future developments, whichare highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 andthe actions to contain COVID-19 or treat its impact, among others.

Oursuccess depends on our ability to protect our intellectual property and our proprietary technologies.

Ourcommercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for ourproduct candidates, proprietary technologies, and their uses as well as our ability to operate without infringing upon the proprietaryrights of others. We can provide no assurance that our patent applications or those of our licensors will result in additionalpatents being issued or that issued patents will afford sufficient protection against competitors with similar technologies, norcan there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties. Evenissued patents may later be found unenforceable or may be modified or revoked in proceedings instituted by third parties beforevarious patent offices or in courts. The degree of future protection for our proprietary rights is uncertain. Only limited protectionmay be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage. Composition-of-matterpatents on the biological or chemical active pharmaceutical ingredients are generally considered to offer the strongest protectionof intellectual property and provide the broadest scope of patent protection for pharmaceutical products, as such patents provideprotection without regard to any method of use or any method of manufacturing. While we have issued patents in the United Stateswe cannot be certain that the claims in our issued patent will not be found invalid or unenforceable if challenged.

Wecannot be certain that the claims in our issued United States methods of use patents will not be found invalid or unenforceableif challenged.

Wecannot be certain that the pending applications covering among others the bioconjugates comprising sulfated polysaccharides; ranpirnaseand other ribonucleases for treating viral diseases; therapeutic compositions comprising exosomes, bioxomes, and redoxomes; automateddevices for supporting cell therapies; immune cells, ribonucleases, or antibodies for treating COVID-19; chimeric antigen receptors(CARs); or cell-conditioned medium will be considered patentable by the United States Patent and Trademark Office (USPTO),and courts in the United States or by the patent offices and courts in foreign countries, nor can we be certain that the claimsin our issued patents will not be found invalid or unenforceable if challenged. Even if our patent applications covering theseinventions issue as patents, the patents protect specific products and may not be enforced against competitors making and marketinga product that has the same activity. Method-of-use patents protect the use of a product for the specified method or for treatmentof a particular indication. These type of patents may not be enforced against competitors making and marketing a productthat provides the same activity but is used for a method not included in the patent. Moreover, even if competitors do not activelypromote their product for our targeted indications, physicians may prescribe these products “off-label.” Althoughoff-label prescriptions may infringe or contribute to the infringement of method-of-use patents, the practice is common and suchinfringement is difficult to prevent or prosecute.

Inaddition, we own or have exclusive rights to twenty eight (28)United States patents, thirty six (36) foreign-issued patents, twenty five (25) pending patent applications in the United States,forty five (45) pending patent applications in foreign jurisdictions, including Australia, Brazil, Canada, China, Europe, HongKong, India, Israel, Japan, Mexico, New Zealand, North Korea, Russia, Singapore, South Africa, and South Korea, and two (2) internationalPatent Cooperation Treaty (“PCT”) patent applications. These patents and patent applications relate, among others,to (1) dendritic and macrophages based vaccines, and their use for treating cancer and viral diseases; (2) compositions comprisingranpirnase and other ribonucleases for treating viral diseases; (3) tumor infiltrating lymphocytes (TILs) and their use for treatingcancer; (4) compositions comprising immune cells, ribonucleases, or antibodies for treating COVID-19; (5) whole-cell antiviralvaccines; (6) therapeutic compositions comprising exosomes, bioxomes, and redoxomes; (7)bioreactors for cell culture and automatedsystems and devices for supporting cell therapies; and(8) scaffolds, including alginate and sulfated alginate scaffolds, polysaccharidesthereof, and scaffolds for use for cell propagation, transplantations, and in the treatment of autoimmune diseases.

Wehave pending U.S. patent applications directed, among others, to dendritic and macrophages based vaccines, and their use fortreating cancer and viral diseases. If issued, this application would expire in 2038.

Wehave pending U.S. patent applications directed, among others, to compositions comprising ranpirnase and other ribonucleases fortreating viral diseases. If issued, these applications would expire between 2039 and 2040. Counterpart patents applications werefiled in Australia, Canada, China, Europe, Hong Kong, Japan, Mexico, New Zealand, North Korea, Russian Federation, Singapore,South Africa, and were also filed as International (“PCT”) applications. If issued, these applications would expirebetween 2035 and 2037. These expiration dates do not include any patent term extensions that might be available following thegrant of marketing authorizations.

Wehave pending U.S. patent applications directed, among others, to therapeutic compositions comprising exosomes, bioxomes, and redoxomes.If issued, these applications would expire in 2040. Counterpart patents applications were filed in Australia, Brazil, Canada,China, Europe, India, Israel, India, Japan and South Korea. If issued, these applications would expire in 2039. These expirationdates do not include any patent term extensions that might be available following the grant of marketing authorizations.

Wehave pending U.S. patent applications directed, among others, to automated devices for supporting cell therapies. If issued, theseapplications would expire between 2035 and 2038.

Wehave a pending U.S. provisional patent application directed, among others, to tumor infiltrating lymphocytes (TILs) and theiruse for treating cancer. If converted into a non-provisional application and issued, this application would expire in 2041, withoutincluding any patent term extensions that might be available following the grant of marketing authorizations.

Wehave pending U.S. provisional patent applications directed, among others, to compositions comprising immune cells, ribonucleases,or antibodies for treating COVID-19. If converted into a non-provisional application and issued, this application would expirein 2041, without including any patent term extensions that might be available following the grant of marketing authorizations.

Granted U.S. patents,which are directed among others to scaffolds, including alginate and sulfated alginate scaffolds, polysaccharides thereof, andscaffolds for use for cell propagation, transplantations, and in the treatment of autoimmune diseases, will expire between 2025and 2036. Counterpart patents granted in Australia, France, Germany, Israel, Switzerland, and the United Kingdom, will expirebetween 2026 and 2035. These expiration dates do notinclude any patent term extensions that might be available following the grant of marketing authorizations.

We have pending U.S.patent applications directed, among others, to bioconjugates comprising sulfated polysaccharides and diverse bioactive peptides,and their use in the treatment of inflammatory conditions. If issued, these applications would expire in 2038. Counterpart patentsapplications were filed in China, Europe, Israel, Japan, and South Korea. If issued, these applications would expire between 2026and 2038. These expiration dates do not include any patent term extensions that might be available following the grant of marketingauthorizations.

OrgenesisLtd, has exclusive rights to six (6) United States patents, fourteen (14) foreign-issued patents, five (5) pending patent applicationsin the United States, twenty six (26) pending patent applications in foreign jurisdictions, including Australia, Brazil, Canada,China, Europe, India, Israel, Japan, Mexico, Panama, Singapore, and South Korea. These patents and patent applications relate,among others, to the trans-differentiation of cells (including hepatic cells) to cells having pancreatic β-cell-like phenotypeand function and to their use in the treatment of degenerative pancreatic disorders, including diabetes, pancreatic cancer andpancreatitis. Granted U.S. patents, which are directed among others to trans-differentiation to pancreatic β-cell-like phenotypeand function cells and to their use in the treatment of degenerative pancreatic disorders, including diabetes, pancreatic cancerand pancreatitis, will expire between 2024 and 2035. Counterpart patents granted in Australia, France, Germany, Israel, Switzerland,and the United Kingdom, will expire between 2024 and 2035. These expiration dates do not include any patent term extensions thatmight be available following the grant of marketing authorizations.

OrgenesisLtd, has pending U.S. patent applications directed, among others, to the trans-differentiation of cells, to cells having pancreaticβ-cell-like phenotype and function and to their use in the treatment of degenerative pancreatic disorders, including diabetes,pancreatic cancer and pancreatitis. If issued, these applications would expire between 2038 and 2040. Counterpart patents applicationswere filed in Australia, Brazil, Canada, China, Europe, India, Israel, Mexico, Panama, Singapore, South Korea, and were also filedas International (“PCT”) applications. If issued, these applications would expire between 2034 and 2039. These expirationdates do not include any patent term extensions that might be available following the grant of marketing authorizations.

Thepatent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of ourfuture development partners will be successful in protecting our product candidates by obtaining and defending patents. Theserisks and uncertainties include the following:

●	the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case;
●	patent applications may not result in any patents being issued;
●	patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;
●	our competitors, many of whom have substantially greater resources and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use, and sell our potential product candidates;
●	there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and
●	countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates.

Inaddition, we rely on the protection of our trade secrets and proprietary know-how. Although we have taken steps to protect ourtrade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidentialinformation and inventions agreements with employees, consultants and advisors, we cannot provide any assurances that all suchagreements have been duly executed, and third parties may still obtain this information or may come upon this or similar informationindependently. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficientrecourse against third parties for misappropriating its trade secrets. If any of these events occurs or if we otherwise lose protectionfor our trade secrets or proprietary know-how, our business may be harmed.

Ifproduct liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercializationof our product candidates.

Weface an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an evengreater risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived tocause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such productliability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherentin the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protectionacts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or berequired to limit commercialization of our product candidates. Even a successful defense would require significant financial andmanagement resources. Regardless of the merits or eventual outcome, liability claims may result in:

●	decreased demand for our products;
●	injury to our reputation;
●	withdrawal of clinical trial participants and inability to continue clinical trials;
●	initiation of investigations by regulators;
●	costs to defend the related litigation;
●	a diversion of management’s time and our resources;
●	substantial monetary awards to trial participants or patients;
●	product recalls, withdrawals or labeling, marketing or promotional restrictions;
●	loss of revenue;
●	exhaustion of any available insurance and our capital resources;
●	the inability to commercialize any product candidate; and
●	a decline in our share price.

Becausemost of our products have not reached commercial stage, we do not currently need to carry clinical trial or extensive productliability insurance. In the future, our inability to obtain additional sufficient product liability insurance at an acceptablecost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop,alone or with collaborators. Such insurance policies may also have various exclusions, and we may be subject to a product liabilityclaim for which we have no coverage.

Itmay be difficult to enforce a U.S. judgment against us, our officers and directors and the foreign persons named in this AnnualReport on Form 10-K in the United States or in foreign countries, or to assert U.S. securities laws claims in foreign countriesor serve process on our officers and directors and these experts.

Whilewe are incorporated in the State of Nevada, currently a majority of our directors and executive officers are not residents ofthe United States, and the foreign persons named in this Annual Report on Form 10-K are located outside of the United States.The majority of our assets are located outside the United States. Therefore, it may be difficult for an investor, or any otherperson or entity, to enforce a U.S. court judgment based upon the civil liability provisions of the U.S. federal securities lawsagainst us or any of these persons in a U.S. or foreign court, or to effect service of process upon these persons in the UnitedStates. Additionally, it may be difficult for an investor, or any other person or entity, to assert U.S. securities law claimsin original actions instituted in foreign countries in which we operate. Foreign courts may refuse to hear a claim based on aviolation of U.S. securities laws on the grounds that foreign countries are not necessary the most appropriate forum in whichto bring such a claim. Even if a foreign court agrees to hear a claim, it may determine that foreign law and not U.S. law is applicableto the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can bea time-consuming and costly process. Certain matters of procedure will also be governed by foreign countries law. There is littlebinding case law in foreign countries addressing the matters described above.

Wemay be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputationaldamage.

Weare subject to laws and regulations covering data privacy and the protection of personal information, including health information.The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasingfocus on privacy and data protection issues which may affect our business. In the U.S., numerous federal and state laws and regulations,including state security breach notification laws, state health information privacy laws, and federal and state consumer protectionlaws, govern the collection, use, disclosure, and protection of personal information. Each of these laws is subject to varyinginterpretations by courts and government agencies, creating complex compliance issues for us. If we fail to comply with applicablelaws and regulations we could be subject to penalties or sanctions, including criminal penalties if we knowingly obtain or discloseindividually identifiable health information from a covered entity in a manner that is not authorized or permitted by the HealthInsurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and ClinicalHealth Act, or HIPAA.

Numerousother countries have, or are developing, laws governing the collection, use and transmission of personal information as well.The EU and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations.In the EU, for example, effective May 25, 2018, the GDPR replaced the prior EU Data Protection Directive (95/46) that governedthe processing of personal data in the European Union. The GDPR imposes significant obligations on controllers and processorsof personal data, including, as compared to the prior directive, higher standards for obtaining consent from individuals to processtheir personal data, more robust notification requirements to individuals about the processing of their personal data, a strengthenedindividual data rights regime, mandatory data breach notifications, limitations on the retention of personal data and increasedrequirements pertaining to health data, and strict rules and restrictions on the transfer of personal data outside of the EU,including to the U.S. The GDPR also imposes additional obligations on, and required contractual provisions to be included in,contracts between companies subject to the GDPR and their third-party processors that relate to the processing of personal data.The GDPR allows EU member states to make additional laws and regulations further limiting the processing of genetic, biometricor health data.

Adoptionof the GDPR increased our responsibility and liability in relation to personal data that we process and may require us to putin place additional mechanisms to ensure compliance. Any failure to comply with the requirements of GDPR and applicable nationaldata protection laws of EU member states, could lead to regulatory enforcement actions and significant administrative and/or financialpenalties against us (fines of up to Euro 20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financialyear, whichever is higher), and could adversely affect our business, financial condition, cash flows and results of operations.

Weare increasingly dependent on information technology and our systems and infrastructure face certain risks, including cybersecurityand data storage risks.

Significantdisruptions to our information technology systems or breaches of information security could adversely affect our business. Inthe ordinary course of business, we collect, store and transmit confidential information, and it is critical that we do so ina secure manner in order to maintain the confidentiality and integrity of such confidential information. Our information technologysystems are potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by ouremployees, partners, vendors, or from attacks by malicious third parties. Maintaining the secrecy of this confidential, proprietary,and/or trade secret information is important to our competitive business position. While we have taken steps to protect such informationand invested in information technology, there can be no assurance that our efforts will prevent service interruptions or securitybreaches in our systems or the unauthorized or inadvertent wrongful access or disclosure of confidential information that couldadversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive information.A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination or misappropriationor misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking,or other forms of deception, or for any other cause, could enable others to produce competing products, use our proprietary technologyand/or adversely affect our business position. Further, any such interruption, security breach, loss or disclosure of confidentialinformation could result in financial, legal, business, and reputational harm to us and could have a material effect on our business,financial position, results of operations and/or cash flow.

Therecan be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish or maintainrelationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and asa result, we may not be able to generate product revenue.

Avariety of risks associated with operating our business internationally could materially adversely affect our business. We planto seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we, and anypotential collaborators in those jurisdictions, will be subject to additional risks related to operating in foreign countries,including:

●	differing regulatory requirements in foreign countries, unexpected changes in tariffs, trade barriers, price and exchange controls, and other regulatory requirements;
●	economic weakness, including inflation, or political instability in particular foreign economies and markets;
●	compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;
●	foreign taxes, including withholding of payroll taxes;
●	foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
●	difficulties staffing and managing foreign operations;
●	workforce uncertainty in countries where labor unrest is more common than in the United States;
●	potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign laws;
●	challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
●	production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
●	business interruptions resulting from geo-political actions, including war, and terrorism or disease outbreaks (such as the recent outbreak of COVID-19, or the novel coronavirus).

Theseand other risks associated with our planned international operations may materially adversely affect our ability to attain ormaintain profitable operations.

Ifwe are unable to integrate acquired businesses effectively, our operating results may be adversely affected.

Fromtime to time, we seek to expand our business through acquisitions. We may not be able to successfully integrate acquired businessesand, where desired, their product portfolios into ours, and therefore we may not be able to realize the intended benefits. Ifwe fail to successfully integrate acquisitions or product portfolios, or if they fail to perform as we anticipate, our existingbusinesses and our revenue and operating results could be adversely affected. If the due diligence of the operations of acquiredbusinesses performed by us and by third parties on our behalf is inadequate or flawed, or if we later discover unforeseen financialor business liabilities, acquired businesses and their assets may not perform as expected. Additionally, acquisitions could resultin difficulties assimilating acquired operations and, where deemed desirable, transitioning overlapping products into a singleproduct line and the diversion of capital and management’s attention away from other business issues and opportunities.The failure to integrate acquired businesses effectively may adversely impact our business, results of operations or financialcondition.

RisksRelated to Our Trans-Differentiation Technologies for Diabetes

THMis entitled to cancel the THM License Agreement.

Pursuantto the terms of the THM License Agreement with THM, Orgenesis Ltd, the Israeli Subsidiary, must develop, manufacture, sell andmarket the products pursuant to the milestones and time schedule specified in the development plan. In the event the Israeli Subsidiaryfails to fulfill the terms of the development plan under the THM License Agreement, THM shall be entitled to terminate the THMLicense Agreement by providing the Israeli Subsidiary with written notice of such a breach and if the Israeli Subsidiary doesnot cure such breach within one year of receiving the notice. THM may also terminate the THM License Agreement if the IsraeliSubsidiary breaches an obligation contained in the THM License Agreement and does not cure it within 180 days of receiving noticeof the breach. We also run the risk that THM may attempt cancel or, at the very least challenge, the License Agreement with OrgenesisLtd. as we continue to expand our focus to other therapies and business activities. We believe that our expanded focus to suchother therapies and business activities may continue to prompt THM to inquire of such activities as they may relate to our compliancewith the terms or direction of resources toward the THM License Agreement. While we have not received any notice of cancellationof the THM License Agreement, we have received an allegation regarding the scope of the rights by THM that may present futurechallenges for our Israeli Subsidiary to continue to develop, manufacture, sell and market the products pursuant to the milestonesand time schedule specified in the development plan of the THM License Agreement.

Wehave developed a technology that demonstrates the capacity to induce a shift in the developmental fate of cells from the liverand differentiating (converting) them into “pancreatic beta cell-like” insulin-producing cells for patients with diabetes.Our intention is to develop our technology to the clinical stage for regeneration of functional insulin-producing cells, thusenabling normal glucose regulated insulin secretion, via cell therapy. By using therapeutic agents that efficiently convert asub-population of liver cells into pancreatic islets phenotype and function, this approach allows the diabetic patient to be thedonor of his/her own therapeutic tissue and to start producing his/her own insulin in a glucose-responsive manner, thereby eliminatingthe need for insulin injections. Because this is a new approach to treating diabetes, developing and commercializing our productcandidates subjects us to a number of challenges, including:

	●	obtaining regulatory approval from the FDA, EMA and other regulatory authorities that have very limited experience with the commercial development of our technology for diabetes;
	●	developing and deploying consistent and reliable processes for engineering a patient’s liver cells ex vivo and infusing the engineered cells back into the patient;
	●	developing processes for the safe administration of these products, including long-term follow-up for all patients who receive our products;
	●	sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our products;
	●	developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on investment;
	●	establishing sales and marketing capabilities after obtaining any regulatory approval to gain market acceptance; and
	●	maintaining a system of post marketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process.

RisksRelated to Development and Regulatory Approval of Our Therapies and Product Candidates

Researchand development of biopharmaceutical products is inherently risky.

Wemay not be successful in our efforts to use and enhance our technology platform to create a pipeline of product candidates anddevelop commercially successful products. Furthermore, we may expend our limited resources on programs that do not yield a successfulproduct candidate and fail to capitalize on product candidates or diseases that may be more profitable or for which there is agreater likelihood of success. If we fail to develop additional product candidates, our commercial opportunity will be limited.Even if we are successful in continuing to build our pipeline, obtaining regulatory approvals and commercializing additional productcandidates will require substantial additional funding and are prone to the risks of failure inherent in medical product development.Investment in biopharmaceutical product development involves significant risk that any potential product candidate will fail todemonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, and become commercially viable. We cannotprovide you any assurance that we will be able to successfully advance any of these additional product candidates through thedevelopment process. Our research programs may initially show promise in identifying potential product candidates, yet fail toyield product candidates for clinical development or commercialization for many reasons, including the following:

●	our platform may not be successful in identifying additional product candidates;
●	we may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates;
●	our product candidates may not succeed in preclinical or clinical testing;
●	a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
●	competitors may develop alternatives that render our product candidates obsolete or less attractive;
●	product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;
●	the market for a product candidate may change during our program so that the continued development of that product candidate is no longer reasonable;
●	a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and
●	a product candidate may not be accepted as safe and effective by patients, the medical community or third- party payers, if applicable.

Ifany of these events occur, we may be forced to abandon our development efforts for a program or programs, or we may not be ableto identify, discover, develop, or commercialize additional product candidates, which would have a material adverse effect onour business and could potentially cause us to cease operations.

Extensiveindustry regulation has had, and will continue to have, a significant impact on our business, especially our product development,manufacturing and distribution capabilities.

Allpharmaceutical companies are subject to extensive, complex, costly and evolving government regulation. For the U.S., this is principallyadministered by the FDA and to a lesser extent by the Drug Enforcement Administration (“DEA”) and state governmentagencies, as well as by varying regulatory agencies in foreign countries where products or product candidates are being manufacturedand/or marketed. The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other federal statutes and regulations,and similar foreign statutes and regulations, govern or influence the testing, manufacturing, packing, labeling, storing, recordkeeping, safety, approval, advertising, promotion, sale and distribution of our future products. Under these regulations, we maybecome subject to periodic inspection of our facilities, procedures and operations and/or the testing of our future products bythe FDA, the DEA and other authorities, which conduct periodic inspections to confirm that we are in compliance with all applicableregulations. In addition, the FDA and foreign regulatory agencies conduct pre-approval and post-approval reviews and plant inspectionsto determine whether our systems and processes are in compliance with current good manufacturing practice (“cGMP”)and other regulations. Following such inspections, the FDA or other agency may issue observations, notices, citations and/or warningletters that could cause us to modify certain activities identified during the inspection. FDA guidelines specify that a warningletter is issued only for violations of “regulatory significance” for which the failure to adequately and promptlyachieve correction may be expected to result in an enforcement action. We may also be required to report adverse events associatedwith our future products to FDA and other regulatory authorities. Unexpected or serious health or safety concerns would resultin labeling changes, recalls, market withdrawals or other regulatory actions.

Therange of possible sanctions includes, among others, FDA issuance of adverse publicity, product recalls or seizures, fines, totalor partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, enforcementactions, injunctions, and civil or criminal prosecution. Any such sanctions, if imposed, could have a material adverse effecton our business, operating results, financial condition and cash flows. Under certain circumstances, the FDA also has the authorityto revoke previously granted drug approvals. Similar sanctions as detailed above may be available to the FDA under a consent decree,depending upon the actual terms of such decree. If internal compliance programs do not meet regulatory agency standards or ifcompliance is deemed deficient in any significant way, it could materially harm our business.

TheEuropean Medicines Agency (“EMA”) will regulate our future products in Europe. Regulatory approval by the EMA willbe subject to the evaluation of data relating to the quality, efficacy and safety of our future products for its proposed use.The time taken to obtain regulatory approval varies between countries. Different regulators may impose their own requirementsand may refuse to grant, or may require additional data before granting, an approval, notwithstanding that regulatory approvalmay have been granted by other regulators.

Regulatoryapproval may be delayed, limited or denied for a number of reasons, including insufficient clinical data, the product not meetingsafety or efficacy requirements or any relevant manufacturing processes or facilities not meeting applicable requirements.

Furthertrials and other costly and time-consuming assessments of the product may be required to obtain or maintain regulatory approval.Medicinal products are generally subject to lengthy and rigorous pre-clinical and clinical trials and other extensive, costlyand time-consuming procedures mandated by regulatory authorities. We may be required to conduct additional trials beyond thosecurrently planned, which could require significant time and expense. In addition, even after the technology approval, both inthe U.S. and Europe, we will be required to maintain post marketing surveillance of potential adverse and risk assessment programsto identify adverse events that did not appear during the clinical studies and drug approval process. All of the foregoing couldrequire an investment of significant time and expense.

Wehave generated limited revenue from therapeutic product sales, and our ability to generate any significant revenue from productsales and become profitable depends significantly on our success in a number of factors.

Wehave a limited number of therapeutic products approved for commercial sale, and we have generated only limited revenue from productsales. Our ability to generate revenue of more significant scale and achieve profitability depends significantly on our successin many factors, including:

●	completing research regarding, and nonclinical and clinical development of, our product candidates;
●	obtaining regulatory approvals and marketing authorizations for product candidates for which we complete clinical studies;
●	developing a sustainable and scalable manufacturing process for our product candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing our own manufacturing capabilities and infrastructure;
●	launching and commercializing product candidates for which we obtain regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor;
●	obtaining market acceptance of our product candidates as viable treatment options;
●	addressing any competing technological and market developments;
●	identifying, assessing, acquiring and/or developing new product candidates;
●	negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter;
●	maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and
●	attracting, hiring, and retaining qualified personnel.

Evenif more of the product candidates that we develop are approved for commercial sale, we anticipate incurring significant costsassociated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are requiredby the U.S. Food and Drug Administration, or the FDA, or other regulatory agencies, domestic or foreign, to change our manufacturingprocesses or assays, or to perform clinical, nonclinical, or other types of studies in addition to those that we currently anticipate.If we are successful in obtaining regulatory approvals to market more of our product candidates, our revenue will be dependent,in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product,the ability to get reimbursement at any price, and whether we own the commercial rights for that territory. If the number of ouraddressable disease patients is not as significant as we estimate, the indication approved by regulatory authorities is narrowerthan we expect, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatmentguidelines, we may not generate significant revenue from sales of such products, even if approved. If we are not able to generaterevenue from the sale of any approved products, we may never become profitable.

Whenwe commence any clinical trials, we may not be able to conduct our trials on the timelines we expect.

Clinicaltesting is expensive, time consuming, and subject to uncertainty. We cannot guarantee that any clinical studies will be conductedas planned or completed on schedule, if at all. We expect that our early clinical work will help support the filing with the FDAof an IND for our product in fiscal 2020. However, we cannot be sure that we will be able to submit an IND in this time-frame,and we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin. Moreover, even if thesetrials begin, issues may arise that could suspend or terminate such clinical trials. A failure of one or more clinical studiescan occur at any stage of testing, and our future clinical studies may not be successful. Events that may prevent successful ortimely completion of clinical development include:

●	the inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical studies;
●	delays in reaching a consensus with regulatory agencies on study design;
●	delays in establishing CMC (Chemistry, Manufacturing, and Controls) which is a cornerstone in clinical study submission and later on, the regulatory approval;
●	the FDA not allowing us to use the clinical trial data from a research institution to support an IND if we cannot demonstrate the comparability of our product candidates with the product candidate used by the relevant research institution in its clinical studies;
●	delays in obtaining required Institutional Review Board, or IRB, approval at each clinical study site;
●	imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application or amendment, or equivalent application or amendment;

●	a result of a new safety finding that presents unreasonable risk to clinical trial participants;
●	a negative finding from an inspection of our clinical study operations or study sites;
●	developments on trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly;
●	if the FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;
●	delays in recruiting suitable patients to participate in our clinical studies;
●	difficulty collaborating with patient groups and investigators;
●	failure to perform in accordance with the FDA’s current good clinical practices, or cGCPs, requirements, or applicable regulatory guidelines in other countries;
●	delays in having patients’ complete participation in a study or return for post-treatment follow-up;
●	patients dropping out of a study;
●	occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;
●	changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;
●	changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;
●	the cost of clinical studies of our product candidates being greater than we anticipate;
●	clinical studies of our product candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical studies or abandon product development programs; and
●	delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical studies or the inability to do any of the foregoing.

Anyinability to successfully complete preclinical and clinical development could result in additional costs to us or impair our abilityto generate revenue. In addition, if we make manufacturing or formulation changes to our product candidates, we may be requiredto, or we may elect to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical studydelays could also shorten any periods during which our products have patent protection and may allow our competitors to bringproducts to market before we do, which could impair our ability to successfully commercialize our product candidates and may harmour business and results of operations.

Ourclinical trial results may also not support approval, whether accelerated approval, conditional marketing authorizations, or regularapproval. The results of preclinical and clinical studies may not be predictive of the results of later-stage clinical trials,and product candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressedthrough preclinical studies and initial clinical trials. In addition, our product candidates could fail to receive regulatoryapproval for many reasons, including the following:

●	the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
●	the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval;
●	we may be unable to demonstrate that our product candidates’ risk-benefit ratios for their proposed indications are acceptable;
●	the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
●	we may be unable to demonstrate that the clinical and other benefits of our product candidates outweigh their safety risks;
●	the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
●	the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to obtain regulatory approval in the United States or elsewhere;
●	the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, our own manufacturing facilities, or our third-party manufacturers’ facilities with which we contract for clinical and commercial supplies; and
●	the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Further,failure to obtain approval for any of the above reasons may be made more likely by the fact that the FDA and other regulatoryauthorities have very limited experience with commercial development of our cell therapy for the treatment of Type 1 Diabetes.

Ourproduct candidates may cause undesirable side effects or have other properties that could halt their clinical development, preventtheir regulatory approval, limit their commercial potential, or result in significant negative consequences.

Aswith most biological drug products, use of our product candidates could be associated with side effects or adverse events whichcan vary in severity from minor reactions to death and in frequency from infrequent to prevalent. Any of these occurrences maymaterially and adversely harm our business, financial condition and prospects.

Ourproduct candidates are biologics and the manufacture of our product candidates is complex and we may encounter difficulties inproduction, particularly with respect to process development or scaling-out of our manufacturing capabilities.

Ifwe encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products forpatients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure. Ourproduct candidates are biologics and the process of manufacturing our products is complex, highly regulated and subject to multiplerisks. As a result of the complexities, the cost to manufacture biologics is generally higher than traditional small moleculechemical compounds, and the manufacturing process is less reliable and is more difficult to reproduce.

Ourmanufacturing process will be susceptible to product loss or failure due to logistical issues associated with the collection ofliver cells, or starting material, from the patient, shipping such material to the manufacturing site, shipping the final productback to the patient, and infusing the patient with the product, manufacturing issues associated with the differences in patientstarting materials, interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installationor operation of equipment, vendor or operator error, inconsistency in cell growth, failures in process testing and variabilityin product characteristics. Even minor deviations from normal manufacturing processes could result in reduced production yields,product defects, and other supply disruptions. If for any reason we lose a patient’s starting material or later-developedproduct at any point in the process, the manufacturing process for that patient will need to be restarted and the resulting delaymay adversely affect that patient’s outcome. If microbial, viral, or other contaminations are discovered in our productcandidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may needto be closed for an extended period of time to investigate and remedy the contamination. Because our product candidates are manufacturedfor each particular patient, we will be required to maintain a chain of identity and tractability of all reagents and virusesinvolved in the process with respect to materials as they move from the patient to the manufacturing facility, through the manufacturingprocess, and back to the patient. Maintaining such a chain of identity is difficult and complex, and failure to do so could resultin adverse patient outcomes, loss of product, or regulatory action including withdrawal of our products from the market. Further,as product candidates are developed through preclinical to late stage clinical trials towards approval and commercialization,it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effortto optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any ofthese changes could cause our product candidates to perform differently and affect the results of planned clinical trials or otherfuture clinical trials.

Althoughwe are working to develop commercially viable processes, doing so is a difficult and uncertain task, and there are risks associatedwith scaling to the level required for advanced clinical trials or commercialization, including, among others, cost overruns,potential problems with process scale-out, process reproducibility, stability issues, lot consistency, and timely availabilityof reagents or raw materials. We may ultimately be unable to reduce the cost of goods for our product candidates to levels thatwill allow for an attractive return on investment if and when those product candidates are commercialized.

Inaddition, the manufacturing process for any products that we may develop is subject to FDA and foreign regulatory authority approvalprocess, and we will need to contract with manufacturers who can meet all applicable FDA and foreign regulatory authority requirementson an ongoing basis. If we are unable to reliably produce products to specifications acceptable to the FDA or other regulatoryauthorities, we may not obtain or maintain the approvals we need to commercialize such products. Even if we obtain regulatoryapproval for any of our product candidates, there is no assurance that either we or our subsidiaries and joint ventures will beable to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce itin sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand.Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one ormore clinical trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization efforts,increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and growthprospects.

Themanufacture of biological drug products is complex and requires significant expertise and capital investment, including the developmentof advanced manufacturing techniques and process controls. Manufacturers of biologic products often encounter difficulties inproduction, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturingprocess (including the absence of contamination). These problems include logistics and shipping, difficulties with productioncosts and yields, quality control, including stability of the product, product testing, operator error, availability of qualifiedpersonnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants arediscovered in our supply of our product candidates or in the manufacturing facilities, such manufacturing facilities may needto be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any stabilityfailures or other issues relating to the manufacture of our product candidates will not occur in the future. Additionally, ourmanufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstablepolitical environments. If our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with theircontractual obligations, our ability to provide our product candidate to patients in clinical trials would be jeopardized. Anydelay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costsassociated with maintaining clinical trial programs and, depending upon the period of delay, require us to begin new clinicaltrials at additional expense or terminate clinical trials completely.

Cell-basedtherapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be availableto us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on sole sourcevendors or a limited number of vendors, which could impair our ability to manufacture and supply our products.

Manufacturingour product candidates will require many reagents and viruses, which are substances used in our manufacturing processes to bringabout chemical or biological reactions, and other specialty materials and equipment, some of which are manufactured or suppliedby small companies with limited resources and experience to support commercial biologics production. We currently depend on alimited number of vendors for certain materials and equipment used in the manufacture of our product candidates. Some of thesesuppliers may not have the capacity to support commercial products manufactured under GMP by biopharmaceutical firms or may otherwisebe ill-equipped to support our needs. We also do not have supply contracts with many of these suppliers and may not be able toobtain supply contracts with them on acceptable terms or at all. Accordingly, we may experience delays in receiving key materialsand equipment to support clinical or commercial manufacturing.

Forsome of these reagents, viruses, equipment, and materials, we rely and may in the future rely on sole source vendors or a limitednumber of vendors. An inability to continue to source product from any of these suppliers, which could be due to regulatory actionsor requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputesor shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates,which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials,either of which could significantly harm our business.

Aswe continue to develop and scale our manufacturing process, we expect that we will need to obtain rights to and supplies of certainmaterials and equipment to be used as part of that process. We may not be able to obtain rights to such materials on commerciallyreasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of suchmaterials or find a suitable substitute, it would have a material adverse effect on our business.

Therecan be no assurance that we will be able to further develop in-house sales and commercial distribution capabilities or establishor maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas,and as a result, we may not be able to generate product revenue.

Avariety of risks associated with operating our business internationally could materially adversely affect our business. We planto seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we, and anypotential collaborators in those jurisdictions, will be subject to additional risks related to operating in foreign countries,including:

●	differing regulatory requirements in foreign countries, unexpected changes in tariffs, trade barriers, price and exchange controls, and other regulatory requirements;
●	economic weakness, including inflation, or political instability in particular foreign economies and markets;
●	compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;
●	foreign taxes, including withholding of payroll taxes;
●	foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
●	difficulties staffing and managing foreign operations;
●	workforce uncertainty in countries where labor unrest is more common than in the United States;
●	potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign laws;
●	challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
●	production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
●	business interruptions resulting from geo-political actions, including war and terrorism.

Theseand other risks associated with our planned international operations may materially adversely affect our ability to attain ormaintain profitable operations.

Weface significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if wefail to compete effectively.

Thebiopharmaceutical industry, and the rapidly evolving market for developing cell-based therapies is characterized by intense competitionand rapid innovation. Our competitors may be able to develop other compounds or drugs that are able to achieve similar or betterresults. Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies,specialty pharmaceutical companies, universities, and other research institutions. Many of our competitors have substantiallygreater financial, technical and other resources, such as larger research and development staff and experienced marketing andmanufacturing organizations as well as established sales forces. Smaller or early-stage companies may also prove to be significantcompetitors, particularly through collaborative arrangements with large, established companies. Mergers and acquisitions in thebiotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. Competitionmay increase further as a result of advances in the commercial applicability of technologies and greater availability of capitalfor investment in these industries. Our competitors, either alone or with collaborative partners, may succeed in developing, acquiringor licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized, or lesscostly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for thedevelopment of our technologies and products.

Weare highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualifiedpersonnel, we may not be able to successfully implement our business strategy.

Ourability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract,motivate and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on our senior management,particularly our Chief Executive Officer, Vered Caplan. The loss of the services of any of our executive officers, other key employees,and other scientific and medical advisors, and our inability to find suitable replacements, could result in delays in productdevelopment and harm our business. Competition for skilled personnel is intense and the turnover rate can be high, which may limitour ability to hire and retain highly qualified personnel on acceptable terms or at all.

Toinduce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided stock option grantsthat vest over time. The value to employees of these equity grants that vest over time may be significantly affected by movementsin our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers from othercompanies. Although we have employment agreements with our key employees, most these employment agreements provide for at-willemployment, which means that any of our employees could leave our employment at any time, with or without notice. We do not maintain“key man” insurance policies on the lives of all of these individuals or the lives of any of our other employees.

RisksRelated to our Common Stock

Ifwe issue additional shares in the future, it will result in the dilution of our existing stockholders.

Ourarticles of incorporation authorizes the issuance of up to 145,833,334 shares of our common stock with a par value of $0.0001per share. Our Board of Directors may choose to issue some or all of such shares to acquire one or more companies or productsand to fund our overhead and general operating requirements. The issuance of any such shares will reduce the book value per shareand may contribute to a reduction in the market price of the outstanding shares of our common stock. If we issue any such additionalshares, such issuance will reduce the proportionate ownership and voting power of all current stockholders. Further, such issuancemay result in a change of control of our company.

Ourstock price and trading volume may be volatile, which could result in losses for our stockholders.

Theequity trading markets have recently experienced high volatility resulting in highly variable and unpredictable pricing of equitysecurities. If the turmoil in the equity trading markets continues, the market for our common stock could change in ways thatmay not be related to our business, our industry or our operating performance and financial condition. In addition, the tradingvolume in our common stock may fluctuate and cause significant price variations to occur. Some of the factors that could negativelyaffect our share price or result in fluctuations in the price or trading volume of our common stock include:

●	actual or anticipated quarterly variations in our operating results;
●	changes in expectations as to our future financial performance or changes in financial estimates, if any;
●	announcements relating to our business;
●	conditions generally affecting the biotechnology industry;
●	the success of our operating strategy; and
●	the operating and stock performance of other comparable companies.

Manyof these factors are beyond our control, and we cannot predict their potential effects on the price of our common stock. In addition,the stock market is subject to extreme price and volume fluctuations. During the past 52 weeks ended December 31, 2020, our stockprice has fluctuated from a low of $2.76 to a high of $7.84. This volatility has had a significant effect on the market priceof securities issued by many companies for reasons unrelated to their operating performance and could have the same effect onour common stock.

Noassurance can be provided that a purchaser of our common stock will be able to resell their shares of common stock at or abovethe price that they acquired those shares. We can provide no assurances that the market price of common stock will increase orthat the market price of common stock will not fluctuate or decline significantly.

Wedo not intend to pay dividends on any investment in the shares of stock of our company.

Wehave never paid any cash dividends, and currently do not intend to pay any dividends for the foreseeable future. The Board ofDirectors has not directed the payment of any dividends and does not anticipate paying dividends on the shares for the foreseeablefuture and intends to retain any future earnings to the extent necessary to develop and expand our business. Payment of cash dividends,if any, will depend, among other factors, on our earnings, capital requirements, and the general operating and financial condition,and will be subject to legal limitations on the payment of dividends out of paid-in capital. Because we do not intend to declaredividends, any gain on an investment in our company will need to come through an increase in the stock’s price. This maynever happen, and investors may lose all of their investment in our company.

ITEM1B. UNRESOLVED STAFF COMMENTS

Notapplicable.

ITEM2. PROPERTIES

Wedo not own any real property. A description of the leased premises we utilize in several of our facilities is as follows:

Entity		Property Description
Orgenesis Inc./Orgenesis Maryland Inc.		These are our principal offices: ●   Located at 20271 Goldenrod Lane, Germantown, MD 20876. ●   Occupy office space at the Germantown Innovation Center. ●   Cost is $200 per month on a month-to-month contract.
Orgenesis Ltd.		●   The development lab is located in the Bar Lev Industrial Park M.P. MISGAV, Israel. ●   Offices are in the science park of Ness Ziona. Monthly costs are approximately $5 thousand.
Orgenesis Korea		●   Operational production and Office area represent approximately 2,234 square meters. ●   Monthly costs are approximately 21,232 thousand KRW, or approximately $19 thousand. ●   Lease agreement for the office and operational production area expires on January 1, 2023.
Koligo Therapeutics Inc.		●   Production facility and development labs in New Albany, Indiana – approximately 4170 square feet (388 square meter) at monthly costs of about $5400 ●   Medical device maintenance and development labs in Leander, Texas – approximately 2000 square feet (186 square meter) at monthly costs of about $2500
Orgenesis Biotech Israel (previously Atvio Biotech)		●   Located in the Bar Lev Industrial Park M.P. MISGAV, Israel. ●   Operational production and Office area represent +/-1,264 m². ●   Monthly costs are approximately $10.5 thousand. ●   Lease agreement for the office and operational production area expires on July 31, 2023.
Orgenesis Belgium		●   Located near Namur, at Novalis Science Park, Orgenesis Belgium

Webelieve that our facilities are generally in good condition and suitable to carry on our business. We also believe that, if required,suitable alternative or additional space will be available to us on commercially reasonable terms.

ITEM3. LEGAL PROCEEDINGS

Weare not involved in any pending legal proceedings that we anticipate would result in a material adverse effect on our businessor operations.

ITEM4. MINE SAFETY DISCLOSURES

Notapplicable.

PARTII

ITEM5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

MarketInformation

UntilMarch 13, 2018, our common shares were traded under OTC Market Group’s OTCQB. Since March 13, 2018, our commonstock has been listed for trading on the Nasdaq Capital Market (“Nasdaq CM”) under the symbol “ORGS.”

Asof March 9, 2021, there were 205 holders of record of our common stock, and the last reported sale price of ourcommon stock on the NasdaqCM on March 8, 2021 was $7.26. A significant number of shares of our common stock areheld in either nominee name or street name brokerage accounts, and consequently, we are unable to determine the total numberof beneficial owners of our stock.

DividendPolicy

Todate, we have paid no dividends on our common stock and do not expect to pay cash dividends in the foreseeable future. We planto retain all earnings to provide funds for the operations of our company. In the future, our Board of Directors will decide whetherto declare and pay dividends based upon our earnings, financial condition, capital requirements, and other factors that our Boardof Directors may consider relevant. We are not under any contractual restriction as to present or future ability to pay dividends.

UnregisteredSales of Equity Securities

Duringthe fiscal year ended December 31, 2020, our financing activities consisted of the following:

OnJanuary 20, 2020, we entered into a Securities Purchase Agreement with certain investors pursuant to which we issued and sold,in a private placement (the “Offering”), 2,200,000 shares of Common Stock at a purchase price of $4.20 per share andwarrants to purchase up to 1,000,000 shares of Common Stock at an exercise price of $5.50 per share, which are exercisable betweenJune 2021 and January 2023. We received gross proceeds of approximately $9.24 million before deducting related offering expensesin the amount of $0.8 million.

OnApril 7, 2020, we entered into an Asset Purchase Agreement (the “Tamir Purchase Agreement”) with Tamir Biotechnology,Inc. (“Tamir”), pursuant to which we agreed to acquire certain assets and liabilities of Tamir related to the discovery,development and testing of therapeutic products for the treatment of diseases and conditions in humans, including all rights toranpirnase and use for antiviral therapy (collectively, the “Purchased Assets and Assumed Liabilities” and such acquisition,the “Tamir Transaction”). The Tamir Transaction closed on April 23, 2020. As aggregate consideration for the acquisition,we paid $2.5 million in cash and issued an aggregate of 3,400,000 shares of common stock to Tamir resulting in a total considerationof $20.2 million.

OnSeptember 26, 2020, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) byand among the Company, Orgenesis Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“MergerSub”), Koligo Therapeutics Inc., a Kentucky corporation (“Koligo”), the shareholders of Koligo (collectively,the “Shareholders”) and Long Hill Capital V, LLC, solely in its capacity as the representative, agent and attorney-in-factof the Shareholders. The Merger Agreement provided for the acquisition of Koligo by the Company through the merger of Merger Subwith and into Koligo, with Koligo surviving as a wholly-owned subsidiary of the Company (the “Merger”). The Mergerclosed on October 15, 2020.

Pursuantto the terms of the Merger Agreement, an aggregate of 2,061,713 shares of Company common stock were issued to Koligo’s Shareholderswho were accredited investors (with certain Shareholders who were not accredited investors being paid solely in cash in the amountof approximately $20 thousand) in accordance with the terms of the Merger Agreement. In connection with the Merger, the Companyassumed an aggregate of approximately $1.9 million of Koligo’s liabilities, which were substantially all of Koligo’sliabilities at the closing of the Merger. In addition, we issued 66,910 shares to Maxim Group LLC for advisory services inconnection with the Merger.

Allof the securities issued in the transactions described above were issued without registration under the Securities Act in relianceupon the exemptions provided in Section 4(2) or Regulation S of the Securities Act. Except with respect to securities sold pursuantto Regulation S, the recipients of securities in each such transaction acquired the securities for investment only and not witha view to or for sale in connection with any distribution thereof. Appropriate legends were affixed to the share certificatesissued in all of the above transactions. Each of the recipients also represented that they were “accredited investors”within the meaning of Rule 501(a) of Regulation D under the Securities Act or had such knowledge and experience in financial andbusiness matters as to be able to evaluate the merits and risks of an investment in its common stock. All recipients had adequateaccess, through their relationships with the Company and its officers and directors, to information about the Company. None ofthe transactions described above involved general solicitation or advertising.

IssuerPurchases of Equity Securities

OnMay 14, 2020, our Board of Directors approved the stock repurchase plan (the “Stock Repurchase Plan”) pursuant towhich we may, from time to time, purchase up to $10 million of our outstanding shares of common stock. The shares may be repurchasedfrom time to time in privately negotiated transactions or the open market, including pursuant to Rule 10b5-1 trading plans, andin accordance with applicable regulations of the SEC. The timing and exact amount of any repurchases will depend on various factorsincluding, general and business market conditions, corporate and regulatory requirements, share price, alternative investmentopportunities and other factors. The Repurchase Plan commenced on May 29, 2020 and does not obligate us to acquire any specificnumber of shares in any period, and may be expanded, extended, modified, suspended or discontinued by the Board of Directors atany time.

Thefollowing table summarizes the share repurchase activity from the inception of the Stock Repurchase Plan through December 31,2020.

			Total Number of Shares Purchased				Average Price Paid per Share				Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs				Maximum Value that May Yet Be Purchased Under the Plans or Programs
															(in thousands)
October 2020				8,807				4.47				8,807			$	9,960
November 2020				101				4.50				101				9,960
December 2020				46,401				4.47				46,401				9,750
				55,309				4.47				55,309			$	9,750

ITEM6. SELECTED FINANCIAL DATA

Notapplicable.

ITEM7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Thefollowing Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to provide informationnecessary to understand our audited consolidated financial statements for the fiscal years ended December 31, 2020 and December31, 2019 and highlight certain other information which, in the opinion of management, will enhance a reader’s understandingof our financial condition, changes in financial condition and results of operations. In particular, the discussion is intendedto provide an analysis of significant trends and material changes in our financial position and the operating results of our businessduring the year ended December 31, 2020, as compared to the fiscal year ended December 31, 2019. This discussion should be readin conjunction with our consolidated financial statements for the fiscal years ended December 31, 2020 and December 31, 2019 andrelated notes included elsewhere in this Annual Report on Form 10-K. These historical financial statements may not be indicativeof our future performance. This Management’s Discussion and Analysis of Financial Condition and Results of Operations containsnumerous forward-looking statements, all of which are based on our current expectations and could be affected by the uncertaintiesand risks described throughout this filing, particularly in “Item 1A. Risk Factors.”

Thefull extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financialcondition, will depend on future developments that are uncertain, including as a result of new information that may emerge concerningCOVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national andinternational customers and markets. We have made estimates of the impact of COVID-19 within our financial statements, and althoughthere is currently no major impact, there may be changes to those estimates in future periods. Actual results may differ fromthese estimates.

CorporateOverview

OrgenesisInc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies in an affordableand accessible format (“CGTs”).

CGTscan be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are partof a class of medicines referred to as advanced therapy medicinal products (ATMPs). We mostly focus on autologous therapies, withprocesses and systems that are developed for each therapy using a closed and automated processing system approach that is validatedfor compliant production near the patient at their point of care for the treatment of patients. This approach has the potentialto overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial productionof advanced therapies due to their cost prohibitive nature and complex logistics to deliver the treatments to patients (ultimatelylimiting the number of patients that can have access to, or can afford, these therapies).

Toachieve these goals, we have developed a Point of Care Platform comprised of three enabling components: a pipeline of licensed POCare Therapies that are designed to be processed and produced in closed, automated POCare Technology systems acrossa collaborative POCare Network . Via a combination of science, technology, engineering, and networking, we are working toprovide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. We alsodraw on extensive medical expertise to identify promising new autologous therapies to leverage within the POCare Platform eithervia ownership or licensing.

ThePOCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide with a goal ofachieving harmonized, regulated clinical development and production of the therapies.

POCarePlatform Operations via Subsidiaries

Wecurrently conduct our core business operations ourselves and through our subsidiaries which are all wholly-owned except as otherwisestated below (collectively, the “Subsidiaries”). The Subsidiaries are as follows:

UnitedStates

●	Orgenesis Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America and is currently focused on setting up the POCare Network.
●	Koligo Therapeutics Inc. (“Koligo”) is a Kentucky corporation that we acquired in 2020 and is currently focused on developing the POCare network and therapies. .

Europe

●	Orgenesis Belgium SRL (the “Belgian Subsidiary”) is the center of activity in Europe and is currently focused on process development and the preparation of European clinical trials.
●	Orgenesis Switzerland Sarl (the “Swiss Subsidiary”), was incorporated in October 2020, and is currently focused on providing management services to us.

Asia

●	Orgenesis Ltd. in Israel (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services.
●	Orgenesis Biotech Israel Ltd. (“OBI”), is a provider of cell-processing services in Israel.
●	Korea: Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), is a provider of processing and pre-clinical services in Korea. We own 94.12% of the Korean Subsidiary.

CorporateHistory

Wewere incorporated in the state of Nevada on June 5, 2008 under the name Business Outsourcing Services, Inc. Effective August 31,2011, we completed a merger with our subsidiary, Orgenesis Inc., a Nevada corporation, which was incorporated solely to effecta change in its name. As a result, we changed our name from “Business Outsourcing Services, Inc.” to “OrgenesisInc.”

OnOctober 11, 2011, we incorporated Orgenesis Ltd. as our wholly-owned subsidiary under the laws of Israel. On February 2, 2012,Orgenesis Ltd. signed and closed a definitive agreement to license from Tel Hashomer - Medical Research, Infrastructure and ServicesLtd. (“THM”), a private company duly incorporated under the laws of Israel for the development of AIP (AutologousInsulin Producing) cells.

OnNovember 6, 2014, we entered into an agreement with the shareholders of MaSTherCell S.A. to acquire MaSTherCell S.A. On March2, 2015, we closed on the acquisition of MaSTherCell whereby it became an independent, and wholly-owned subsidiary of OrgenesisINC. Through MaSTherCell, we became engaged in the CDMO business.

OnJune 28, 2018, we, Masthercell Global, Great Point Partners, LLC, a manager of private equity funds focused on growing small tomedium sized heath care companies (“Great Point”), and certain of Great Point’s affiliates, entered into a seriesof definitive strategic agreements intended to finance, strengthen and expand our CDMO business. In connection therewith, we,Masthercell Global and GPP-II Masthercell, LLC, a Delaware limited liability company (“GPP-II”) and an affiliate ofGreat Point, entered into a Stock Purchase Agreement (the “SPA”) pursuant to which GPP-II purchased 378,000 sharesof newly designated Series A Preferred Stock of Masthercell Global (the “Masthercell Global Preferred Stock”), representing37.8% of the issued and outstanding share capital of Masthercell Global, for cash consideration to be paid into Masthercell Globalof up to $25 million, subject to certain adjustments (the “Consideration”). At such time, we held 622,000 shares ofMasthercell Global’s Common Stock, representing 62.2% of the issued and outstanding equity share capital of MasthercellGlobal. An initial cash payment of $11.8 million of the Consideration was remitted at closing by GPP-II, with a follow up paymentof $6,600,000 made in each of years 2018 and 2019, or an aggregate of $13.2 million (the “Future Payments”), if (a)Masthercell Global achieved specified EBITDA and revenues targets during each of these years, and (b) the Orgenesis’ shareholdersapproved certain provisions of the Stockholders’ Agreement referred to below on or before December 31, 2020. Both of theseconditions were met and we received both milestone payments.

Contemporaneouswith the execution of the SPA, we and Masthercell Global entered into a Contribution, Assignment and Assumption Agreement pursuantto which we contributed to Masthercell Global our assets relating to the CDMO Business (as defined below), including the CDMOsubsidiaries (the “Corporate Reorganization”). In furtherance thereof, Masthercell Global, as our assignee, acquiredall of the issued and outstanding share capital of OBI, our Israel based CDMO partner since May 2016, and 94.12% of the sharecapital of the Korean Subsidiary, our Korea based CDMO partner since March 2016.

OnAugust 7, 2019, we, Masthercell Global and GPP (the “Parties”) entered into a Transfer Agreement (the “TransferAgreement”). As a result of the Transfer Agreement, Masthercell Global transferred all of its equity interests of OBI andthe Korean Subsidiary to us in exchange for one dollar ($1.00). The Transfer Agreement also contains agreements made with respectto certain intercompany loans. We accounted for the Transfer Agreement as a transaction with non-controlling interest.

DiscontinuedOperations

UntilDecember 31, 2019, we operated the POCare Platform as one of two business separate business segments.

Historically,the second separate business segment was operated as a Contract Development and Manufacturing Organization (“CDMO”)platform, providing third party contract manufacturing and development services for biopharmaceutical companies (the “CDMOBusiness”). The CDMO platform was historically operated mainly through majority owned Masthercell Global (which consistedof the following two subsidiaries: MaSTherCell S.A. in Belgium (“MaSTherCell”), and Masthercell U.S., LLC in the UnitedStates (“Masthercell U.S.”) (collectively, the “Masthercell Global Subsidiaries”)).

InFebruary 2020, we and GPP-II Masthercell LLC (“GPP”) sold 100% of the outstanding equity interests of Masthercell(the “Masthercell Business”), which comprised the majority of our CDMO Business, to Catalent Pharma Solutions, Inc.for an aggregate nominal purchase price of $315 million, subject to customary adjustments (the “Masthercell Sale”).After accounting for GPP’s liquidation preference and equity stake in Masthercell as well as other investor interests inour Belgian subsidiary MaSTherCell, distributions to Masthercell option holders and transaction costs, we received approximately$126.7 million. We incurred an additional approximately $5.6 million in transaction costs.

Wedetermined that the Masthercell Business (“Discontinued Operation”) meets the criteria to be classified as a discontinuedoperation as of the first quarter of 2020. The Discontinued Operation includes the vast majority of the previous CDMO Business,including majority-owned Masthercell, including MaSTherCell, Masthercell U.S. and all of the Masthercell Global Subsidiaries.

Sincethe Masthercell Sale, we entered into new joint venture agreements with new partners in various jurisdictions. This has allowedus to grow our infrastructure and expand our processing sites into new markets and jurisdictions. In addition, we have engagedsome of these joint venture partners to perform research and development services to further develop and adapt our systems anddevices for specific purposes. We have been investing manpower and financial resources to focus on developing, manufacturing androlling out several types of OMPULs to be used and/or distributed through our POCare Network of partners, collaborators, and jointventures.

TheChief Executive Officer (“CEO”) is our chief operating decision-maker who reviews financial informationprepared on a consolidated basis. Effective from the first quarter of 2020, all of our continuing operations are in the point-of-carebusiness via our POCare Platform. Therefore, no segment report has been presented.

OrgenesisInc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies (“CGT”s)in an affordable and accessible format.

CGTscan be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are partof a class of medicines referred to as advanced therapy medicinal products (ATMP). We mostly focus on autologous therapies, withprocesses and systems that are developed for each therapy using a closed and automated processing system approach that is validatedfor compliant production near the patient at their point of care. This approach has the potential to overcome the limitationsof traditional commercial manufacturing methods that do not translate well to commercial production of advanced therapies dueto their cost prohibitive nature and complex logistics to deliver the treatments to patients (ultimately limiting the number ofpatients that can have access to, or can afford, these therapies).

Toachieve these goals, we have developed a Point of Care Platform comprised of three enabling components: a pipeline of licensed POCare Therapies that are designed to be processed and produced in closed, automated POCare Technology systems acrossa collaborative POCare Network . Via a combination of science, technology, engineering, and networking, we are working toprovide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. We alsodraw on extensive medical expertise to identify promising new autologous therapies to leverage within the POCare Platform eithervia ownership or licensing. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitalsworldwide with a goal of achieving harmonized, regulated clinical development and production of the therapies.

MaterialDevelopments During Fiscal 2020

Acquisitionsand Dispositions

Asmentioned above, on February 2, 2020, we entered into a Purchase Agreement with GPP, Masthercell and Catalent Pharma Solutions,Inc. pursuant to which the Sellers sold 100% of the outstanding equity interests of our Masthercell Business for an aggregatenominal purchase price of $315 million, subject to customary adjustments. After accounting for GPP’s liquidation preferenceand equity stake in Masthercell as well as other investor interests in its Belgian subsidiary MaSTherCell, S.A. (“MaSTherCell”),distributions to Masthercell option holders and transaction costs, we received approximately $126.7 million. We incurred an additionalapproximately $5.6 million in transaction costs.

OnApril 7, 2020, we entered into an Asset Purchase Agreement (the “Tamir Purchase Agreement”) with Tamir Biotechnology,Inc. (“Tamir” or “Seller”), pursuant to which we agreed to acquire certain assets and liabilities of Tamirrelated to the discovery, development and testing of therapeutic products for the treatment of diseases and conditions in humans,including all rights to ranpirnase and use for antiviral therapy (collectively, the “Purchased Assets and Assumed Liabilities”and such acquisition, the “Tamir Transaction”). The Tamir Transaction closed on April 23, 2020. As aggregate considerationfor the acquisition, we paid $2.5 million in cash and issued an aggregate of 3,400,000 shares (the “Shares”) of CommonStock to Tamir resulting in a total consideration of $20.2 million.

OnSeptember 26, 2020, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) byand among ourselves, Orgenesis Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“MergerSub”), Koligo Therapeutics Inc., a Kentucky corporation (“Koligo”), the shareholders of Koligo (collectively,the “Shareholders”), and Long Hill Capital V, LLC (“Long Hill”), solely in its capacity as the representative,agent and attorney-in-fact of the Shareholders. The Merger Agreement provides for the acquisition of Koligo by us through themerger of Merger Sub with and into Koligo, with Koligo surviving as our wholly-owned subsidiary (the “Merger”). TheMerger was announced in a Current Report on Form 8-K filed with the Securities and Exchange Commission on October 1, 2020, towhich a copy of the Merger Agreement, along with copies of certain other ancillary agreements, were annexed as exhibits. The Mergerclosed on October 15, 2020.

Koligowas a privately-held US regenerative medicine company. Koligo’s first commercial product is KYSLECEL® (autologous pancreaticislets) for chronic and acute recurrent pancreatitis. Koligo’s 3D-V technology platform incorporates the use of advanced3D bioprinting techniques and vascular endothelial cells to support development of transformational cell and tissue products forserious diseases.

Inaddition, according to the agreement between the parties, we also funded an additional cash consideration of $500 thousand (with$100 thousand of such reducing the ultimate consideration payable to Koligo) for the acquisition of the assets of Tissue Genesis,LLC (“Tissue Genesis”) by Koligo that was consummated on October 14, 2020. The Tissue Genesis assets include the entireinventory of Tissue Genesis Icellator® devices, related kits and reagents, a broad patent portfolio to protect the technology,registered trademarks, clinical data, and existing business relationships for commercial and development stage use of the Icellatortechnology.

PrivatePlacement

OnJanuary 20, 2020, we entered into a Securities Purchase Agreement with certain investors pursuant to which we issued and sold,in a private placement, 2,200,000 shares of Common Stock at a purchase price of $4.20 per share and warrants to purchase up to1,000,000 shares of Common Stock at an exercise price of $5.50 per share which are exercisable between June 2021 and January 2023.We received gross proceeds of approximately $9.24 million before deducting related offering expenses in the amount of $0.8 million.

OtherDevelopments and Agreements During Fiscal 2020

JointVentures, Collaborations and License Agreements During Fiscal 2020

During2020, we entered into joint venture agreements (“JVA”) or amended existing JVAs (“AJVA”) (which supersededprevious JVAs), master service agreements for POC development revenue (“MSA DEV”) and master service agreements forprocured services (“MSA PS”), with third parties as per the following table:

Name of Party (and country of origin)		Nature of Agreement		Territory		Notes
Theracell Advanced Biotechnology		AJVA		Greece, Turkey, Cyprus, Israel, and Balkans		(1)
Broaden Bioscience and Technology Corp		AJVA		Certain projects in China and the Middle East		(1)
Mircod LLC (US)		JVA		Russia		(2)
Image Securities FZC (UAE) (a related party)		AJVA & MSA PS		India		(1)
Cure Therapeutics		JVA		Korea and Japan
Kidney Cure Ltd		JVA		N/A		(5)
Sescom Ltd		JVA		N/A		(6)
Educell D.O.O (Slovenia)		AJVA & MSA PS & MSA DEV		Croatia, Serbia and Slovenia		(1)
Med Centre for Gene and Cell Therapy FZ-LLC (UAE)		AJVA & MSA PS & MSA DEV		UAE		(1)
Mida Biotech B.V. (Netherlands)		AJVA & MSA PS & MSA DEV		Netherlands, Lithuania, Spain, Switzerland, Germany, Belgium and other countries within West Europe		(7)
Butterfly Biosciences Sarl		JVA		N/A		(8)

Notes:

(1)The parties will collaborate in POC processing, regulatory and therapy development including the setting up one or more pointof care processing facilities in institutions or hospitals in the territory, the supply of our products and services within theTerritory, and the clinical development and commercialization of the relevant third-party products worldwide.

(2)The parties will collaborate in POC processing, regulatory and therapy development including the setting up one or more pointof care processing facilities in institutions or hospitals in the territory, the supply of our products and services within theTerritory and clinical, regulatory, development and commercialization of cell and gene therapies in the Territory.

(5)The parties will collaborate in the (i) implementation of a point-of-care strategy; (ii) assessment of the options for developmentand manufacture of various cell-based types (including kidney derived cells, MSC cells, exosomes, gene therapies) development;and (iii) development of protocols and tests for kidney therapies.

(6)The parties will collaborate in (i) the assessment of relevant tools and technologies to be used in our information security system(the “ISS”); (ii) the implementation of the ISS within the Company and in our point-of-care network; and (iii) theoperation and maintenance of the ISS.

(7)The parties will collaborate in POC processing, regulatory and therapy development including the setting up one or more pointof care processing facilities in institutions or hospitals in the territory and the establishment of an induced pluripotent stemcells R&D and automation platforms and other early-stage development activities.

(8)We and Kidney Cure Ltd own 49% and 51%, respectively, of Butterfly Biosciences Sarl (“BB”). BB is the entitythrough which the Kidney Cure JVA activities will be completed.

OtherLicense Agreements

Weare now working on the completion of all the IND enabling requirements in order to get into Phase I studies under the SponsoredResearch Agreement (the “SRA”) and Exclusive License Agreement between ourselves and the Trustees of Columbia Universityin the City of New York, a New York corporation (“Columbia University”). In 2019, we entered into an SRA with ColumbiaUniversity whereby we will provide financial support for studying the utility of serological tumor marker for tumor dynamics monitoring.Also in 2019, we and Columbia University entered into an Exclusive License Agreement (the “Columbia License Agreement”)whereby Columbia University granted to us an exclusive license to discover, develop, manufacture and sell product in the fieldof cancer therapy. In consideration of the licenses granted under the Columbia License Agreement, we shall pay to Columbia University(i) a royalty of 5% of net sales of any patented product sold and (ii) 2.5% of net sales of other products.

OnMay 15, 2019, we entered into a Joint Venture Agreement with SBH Sciences, Inc., a Massachusetts corporation (“SBH”),for the establishment of a joint venture with SBH for the purpose of collaborating in the field of gene and cell therapy development,process and services of bio-exosome therapy products and services in the areas of diabetes, liver cells and skin applications,including wound healing.

InOctober 2019, we concluded a license agreement with Caerus Therapeutics Corporation (a related party), a Virginia company (“Caerus”),pursuant to which Caerus granted us, among others, an exclusive license to all Caerus IP relating to Advance Chemeric AntigenVectors for Targeting Tumors for the development and/or commercialization of certain licensed products. In consideration for thelicense granted to us under this agreement, we shall pay Caerus feasibility fees, annual maintenance fees and royalties of salesof up to 5% and up to 18% of sub-license fees. Through this joint venture, the parties co-develop a novel CART and CAR-NK platformfor the treatment of solid tumors. The development is at a pre-clinical stage.

OnDecember 20, 2019, we and the Regents of the University of California (“University”) entered into a joint researchagreement in the field of therapies and processing technologies according to an agreed upon work plan. According to the agreement,we will pay the University royalties of up to 5% (or up to 20% of sub-licensing sales) in the event of sales that includes certaintypes of University owned IP.

Duringthe third quarter of 2020, we purchased the IP and related EV technology from a service provider (the “Service Provider”)pursuant to an EV agreement (the “EV agreement”). According to the EV agreement, the Service Provider sold to us allof its rights in the EV technology that it had produced, in the amount of $500 thousand, to be paid in installments over the next12 months from September 2020. In addition, the Service Provider granted us an exclusive worldwide license to use the EV IP technologyfor any purpose.

Includedin the purchased assets of the Tamir Biotechnology Inc. acquisition was the assumption by us of a worldwide license to a privatecompany of certain Tamir technologies in the field of treatment, amelioration, mitigation or prevention of diseases or conditionsof the eye and its adnexa in return for certain development and sales milestone payments to be paid to Tamir. This license feeand the right to receive future milestone payments (of up to $11 million assuming that certain milestones are reached) and royalties(of up to $35 million based on net sales milestones), were assumed by us in connection with the Tamir Purchase Agreement togetherwith a less than 10% share interest. To date, no milestones have been reached.

Asmentioned above, included in the Koligo acquisition were the assets of Tissue Genesis, LLC (“Tissue Genesis”). Weare committed to paying the previous owners of Tissue Genesis up to $500 thousand upon the achievement of certain performancemilestones and earn-out payments on future sales provided that in no event will the aggregate of the earn-out payments exceed$4 million.

Resultsof Operations

Comparisonof the Year Ended December 31, 2020 to the Year Ended December 31, 2019.

Ourfinancial results for the year ended December 31, 2020 are summarized as follows in comparison to the year ended December 31,2019:

		Year Ended December 31,
		2020				2019
		(in thousands)
Revenues		$	6,177			$	2,629
Revenues from related party			1,475				1,270
Research and development expenses and Research and development service expenses, net			83,986				14,014
Amortization of intangible assets			478				430
Selling, general and administrative expenses			18,973				11,451
Other income			(4	)			(21	)
Share in income of associated company			(106	)			-
Financial expense, net			1,061				843
Loss from continuing operation before income taxes		$	96,736			$	22,818

Revenues

Thefollowing table shows our revenues by major revenue streams:

		Year Ended December 31,
		2020				2019
		(in thousands)
Revenue stream:
POC and hospital services		$	6,068			$	3,109
Cell process development services			1,584				790
Total		$	7,652			$	3,899

Ourrevenues for the year ended December 31, 2020 were $7,652 thousand, as compared to $3,899 thousand for the year ended December31, 2019, representing an increase of 96%. The increase in revenues for the year ended December 31, 2020 compared to the yearended December 31, 2019 is mainly attributable to increased POC services revenue.

POCservices are mainly the result of agreements between us and our joint venture partners (See note 11). Pursuant to the agreements,we provide certain services in support of partners’ activity. We have signed master services agreements partners in theaggregate amount of over $38 million for services to be provided from 2021 to 2022.

Abreakdown of the revenues per customer that constituted at least 10% of revenues is as follows:

		Year Ended December 31,
		2020				2019
		(in thousands)
Revenue earned:
Customer A		$	2,857			$	1,420
Customer B			1,577				-
Customer C – related party			1,475				1,270
Customer D			1,412				857

Researchand Development and Research and Development Services, net:

		Year Ended December 31,
		2020				2019
		(in thousands)
Salaries and related expenses		$	5,175			$	3,064
Stock-based compensation			481				776
Professional fees and consulting services			3,463				3,419
Lab expenses			2,348				3,229
First Choice JVA (See Note 11)			-				2,741
Tamir Purchase Agreement (See Note 4)			19,225				-
Depreciation expenses, net			603				521
Other research and development expenses			52,887				1,076
Less – grant			(196	)			(812	)
Total		$	83,986			$	14,014

Researchand development expenses for the year ended December 31, 2020 were $83,986 thousand, as compared to $14,014 thousand for the yearended December 31, 2019, representing an increase of 499%.

Theincrease is mainly attributable to the following:

●	expansion of our pipeline of licensed CGTs with a harmonized pathway for regulatory approval;
●	expansionof our POC capacity globally;
●	investmentin automated processing units & processes;
●	developingowned and licensed advanced therapies to enable commercial production;
●	workswith partners to enable efficient closed processing system technologies addressing POCare needs;
●	an increase in salaries and related expenses and other research and development expenses. Additional R&D staff were hired as we expanded our research and development to the evaluation and development of new cell therapies and related technologies in the field of immune-oncology (our novel CD19 CAR-T and CD19.22 CAR-T programs, cellular vaccination for solid cancers, advanced tumor infiltrating lymphocyte, NK-based therapies, etc.), liver pathologies, stem cell-based therapies and other cell-based technologies such as the novel delivery system, Bioxomes. We invested in converting biological processes to GMP-compliant processes as these therapies progress to clinical stage;
●	In 2020 we made significant investments in the development of several types of Orgenesis Mobile Processing Units and Labs (OMPULs) with the expectation of use and/or distribution through our POCare Network of partners, collaborators, and joint ventures. OMPULs are designed for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of potential or approved cell and gene therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as the manufacturing of such CGTs in a consistent and standardized manner in all locations. The design delivers a potential industrial solution for us to deliver CGTs to practically any clinical institution at the point of care; and
●	TheTamir purchase agreement (See Note 4).

Selling,General and Administrative Expenses

		Year Ended December 31,
		2020				2019
		(in thousands)
Salaries and related expenses		$	3,379			$	2,332
Stock-based compensation			1,915				1,855
Accounting and legal fees			6,946				2,388
Professional fees			1,571				1,553
Rent and related expenses			407				214
Business development			3,477				1,148
Expenses related to collaboration with Theracell			-				689
Depreciation expenses, net			101				113
Other general and administrative expenses			1,177				1,159
Total		$	18,973			$	11,451

Selling,general and administrative expenses for the year ended December 31, 2020 were $18,973 thousand, as compared to $11,451 thousandfor the year ended December 31, 2019, representing an increase of 66%. The increase for the year ended December 31, 2020 is primarilyattributable to:

(i)	An increase in salaries and related expenses of $1,047 thousand, as a result of additional managerial appointments and increased salaries;
(ii)	An increase in accounting and legal fees of $4,558 thousand, which is mainly attributable to additional legal fees incurred for recent business and collaboration agreements; and
(iii)	An increase in business development of $2,329 thousand, as a result of increased activities to establish our presence in new markets.

FinancialExpenses, net

		Year Ended December 31,
		2020				2019
		(in thousands)
Decrease in fair value financial liabilities and assets measured at fair value		$	-			$	63
Interest expense on convertible loans and loans			1,254				498
Foreign exchange loss, net			160				395
Other income			(353	)			(113	)
Total		$	1,061			$	843

Financialexpenses, net for the year ended December 31, 2020 were $1,061 thousand, as compared to $843 thousand for the year ended December31, 2019, representing an increase of 26%. The increase for the year ended December 31, 2020 is primarily attributable to an increasein interest expense on convertible loans and loans of $756 thousand.

Taxincome

		Year Ended December 31,
		2020				2019
		(in thousands)
Tax income		$	1,609			$	229
Total		$	1,609			$	229

Taxincome, net for the year ended December 31, 2020 were $1,609 thousand, as compared to $229 thousand for the year endedDecember 31, 2019, representing an increase of 603%.  The increase for the year ended December 31, 2020 is primarilyattributable due to the release of a tax asset up to the amount of Koligo’s net tax liability. SeeNote 4.

DiscontinuedOperations

Discontinuedoperations relate to the Masthercell Business. The following table presents the financial results associated with the MasthercellBusiness operation as reflected in our Consolidated Comprehensive loss:

OPERATIONS		Year Ended December 31,
		2020				2019
		(in thousands):
Revenues		$	2,556			$	31,053
Cost of revenues			1,482				18,318
Cost of research and development and research and development services, net			7				54
Amortization of intangible assets			137				1,631
Selling, general and administrative expenses			1,896				13,886
Other (income) expenses, net			305				(207	)
Operating loss			1,271				2,629
Financial expenses, net			(29	)			31
Loss before income taxes			1,242				2,660
Tax expenses (income)			(30	)			792
Net loss from discontinuing operation, net of tax		$	1,212			$	3,452

Revenuesare attributable to the extension of existing customer service contracts with biotechnology clients and from revenues generatedfrom existing manufacturing agreements. Cost of revenues were in line with the growth in revenues and employment of additionaloperational staff. Selling, general and administrative expenses included additional managerial appointments, increased professionalfees, additional rental space including in the U.S., and an increase of business development expenses.

WorkingCapital

		December 31,
		2020				2019
		(in thousands)
Current assets		$	50,077			$	78,348
Current liabilities		$	16,285			$	42,434
Working capital		$	33,792			$	35,914

Currentassets decreased by $28,271 thousand between December 31, 2019 and December 31, 2020, which was primarily attributable to thefollowing: (i) an increase in cash and cash equivalents due the Masthercell sale; and (ii) an increase in accounts receivableas a result of POC revenues.

Currentliabilities decreased by $26,149 thousand between December 31, 2019 and December 31, 2020, which was primarily attributable tothe following: (i) an increase in accounts payable and accrued expenses due to expanded operations, (ii) an increase in currentmaturities of convertible loans.

Liquidityand Capital Resources

		Year Ended December 31,
		2020				2019
		(in thousands)
Net loss		$	579			$	(26,041	)
Net cash used in operating activities			(78,046	)			(13,220	)
Net cash provided by (used in) investing activities			105,610				(13,778	)
Net cash provided by financing activities			5,881				24,098
Net change in cash and cash equivalents and restricted cash		$	33,445			$	(2,900	)

OnFebruary 2, 2020, we entered into a Stock Purchase Agreement (the “Purchase Agreement”) with GPP-II Masthercell LLC(“GPP” and together with us, the “Sellers”), Masthercell Global Inc. (“Masthercell”) and CatalentPharma Solutions, Inc. (the “Buyer”). Pursuant to the terms and conditions of the Purchase Agreement, on February10, 2020 the Sellers sold 100% of the outstanding equity interests of Masthercell to Buyer (the “Masthercell Sale”)for an aggregate nominal purchase price of $315 million, subject to customary adjustments. After accounting for GPP’s liquidationpreference and equity stake in Masthercell as well as SFPI – FPIM’s interest in MaSTherCell S.A., distributions toMasthercell option holders and transaction costs, we received approximately $126.7 million, of which $7.2 million was used forthe repayment of intercompany loans and payables.

Netcash used in operating activities for the year ended December 31, 2020 was approximately $78 million, as compared to net cashused in operating activities of approximately $13 million for the year ended December 31, 2019. Since the Masthercell Sale, weentered into new joint venture agreements with new partners in various jurisdictions. This has allowed us to grow our infrastructureand expand our processing sites into new markets and jurisdictions. In addition, we engaged some of these joint venture partnersto perform research and development services to further develop and adapt our systems and devices for specific purposes. We investedmanpower and financial resources to focus on developing, manufacturing and rolling out several types of OMPULs to be used and/ordistributed through our POCare Network of partners, collaborators, and joint ventures.

Netcash provided by investing activities for the year ended December 31, 2020 was approximately $106 million, as compared to netcash used in investing activities of approximately $14 million for the year ended December 31, 2019. This was mainly attributableto the Masthercell sale.

Liquidityand Capital Resources Outlook

Basedon our current cash resources and commitments, we believe that we will be able to maintain our current planned activities andexpected level of expenditures for at least 12 months from the date of the issuance of the financial statements. If increasesare incurred in operating costs in general and administrative expenses for facilities expansion, research and development, commercialand clinical activity or if we experience decreases in revenues from customers, we may need to seek additionalfinancing. In addition, additional funds may be necessary to finance some of our collaborations and joint ventures.

InDecember 2018, we entered into a Controlled Equity Offering Sales Agreement, or Sales Agreement, with Cantor Fitzgerald &Co., or Cantor, pursuant to which we may offer and sell, from time to time through Cantor, shares of our common stock having anaggregate offering price of up to $25.0 million. We will pay Cantor a commission rate equal to 3.0% of the aggregate gross proceedsfrom each sale. Shares sold under the Sales Agreement will be offered and sold pursuant to our Shelf Registration Statement onForm S-3 (Registration No. 333-223777) that was declared effective by the Securities and Exchange Commission on March 28, 2018,or the Shelf Registration Statement, and a prospectus supplement and accompanying base prospectus that we filed with the Securitiesand Exchange Commission on December 20, 2018. We have not yet sold any shares of our common stock pursuant to the Sales Agreement.

CriticalAccounting Policies and Estimates

Oursignificant accounting policies are more fully described in the notes to our financial statements included in this Annual Reporton Form 10-K for the fiscal year ended December 31, 2020. We believe that the accounting policies below are critical for one tofully understand and evaluate our financial condition and results of operations.

BusinessCombination

Weallocate the purchase price of an acquired business to the tangible and intangible assets acquired and liabilities assumed basedupon our estimated fair values on the acquisition date. Any excess of the purchase price over the fair value of the net assetsacquired is recorded as goodwill. Acquired in-process backlog, customer relations, brand name know, technology and IPR&D howare recognized at fair value. The purchase price allocation process requires management to make significant estimates and assumptions,especially at the acquisition date with respect to intangible assets. Direct transaction costs associated with the business combinationare expensed as incurred. The allocation of the consideration transferred in certain cases may be subject to revision based onthe final determination of fair values during the measurement period, which may be up to one year from the acquisition date. Weinclude the results of operations of the business that we have acquired in our consolidated results prospectively from the dateof acquisition.

Ifthe business combination is achieved in stages, the acquisition date carrying value of the acquirer’s previously held equityinterest in the acquiree is re-measured to fair value at the acquisition date; any gains or losses arising from such re-measurementare recognized in profit or loss.

Goodwill

Goodwillrepresents the excess of consideration transferred over the value assigned to the net tangible and identifiable intangible assetsof businesses acquired. Goodwill is allocated to reporting units expected to benefit from the business combination. Goodwillis not amortized but rather tested for impairment at least annually in the fourth quarter, or more frequentlyif events or changes in circumstances indicate that goodwill may be impaired. Following the sale of Masthercell, wemanage the business as one operating segment and one reporting unit. Goodwill impairment is recognized when the quantitativeassessment results in the carrying value exceeding the fair value, in which case an impairment charge is recorded to theextent the carrying value exceeds the fair value.

Therewere no impairment charges to goodwill during the periods presented.

Impairmentof Long-lived Assets

Wewill periodically evaluate the carrying value of long-lived assets to be held and used when events and circumstances warrant sucha review. The carrying value of a long-lived asset is considered impaired when the anticipated undiscountedcash flow from such asset is separately identifiable and is less than its carrying value. In that event, a loss is recognizedbased on the amount by which the carrying value exceeds the fair value of the long-lived asset. Fair value is determined primarilyusing the anticipated cash flows discounted at a rate commensurate with the risk involved. Losses on long-lived assets to be disposedof are determined in a similar manner, except that fair values are reduced for the cost to dispose.

IncomeTaxes

Deferredincome tax assets and liabilities are computed for differences between the financial statement and tax basis of assets and liabilitiesthat will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periodsin which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reducedeferred tax assets to the amount expected to be realized. Income tax expense is the tax payable or refundable for the periodplus or minus the change during the period in deferred tax assets and liabilities.

Inaddition, our management performs an evaluation of all uncertain income tax positions taken or expected to be taken in the courseof preparing our income tax returns to determine whether the income tax positions meet a “more likely than not” standardof being sustained under examination by the applicable taxing authorities. This evaluation is required to be performed for allopen tax years, as defined by the various statutes of limitations, for federal and state purposes.

ASC606 - Revenue from Contracts with Customers

Ouragreements are primarily service contracts that range in duration. We recognize revenue when control of these services is transferredto the customer for an amount, referred to as the transaction price, which reflects the consideration to which we are expectedto be entitled in exchange for those goods or services.

Acontract with a customer exists only when:

●	theparties to the contract have approved it and are committed to perform their respective obligations;
●	wecan identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”);
●	wecan determine the transaction price for the goods or services to be transferred; and
●	thecontract has commercial substance and it is probable that we will collect the consideration to which it will be entitled in exchangefor the goods or services that will be transferred to the customer.

Forthe majority of our contracts, we receive non-refundable upfront payments. We do not adjust the promised amount of considerationfor the effects of a significant financing component since we expect, at contract inception, that the period between the timeof transfer of the promised goods or services to the customer and the time the customer pays for these goods or services to begenerally one year or less. Our credit terms to customers are in average between thirty and ninety days.

Wedo not disclose the value of unsatisfied performance obligations for contracts with original expected duration of one year orless.

Disaggregationof Revenue

Thefollowing table disaggregates our revenues by major revenue streams:

		Year Ended December 31,
Revenue stream:		2020				2019
		(in thousands)
POC and hospital services		$	6,068			$	3,109
Cell process development services			1,584				790
Total		$	7,652			$	3,899

Natureof Revenue Streams

Wehave two main revenue streams being cell process development services and POC development services which includes and hospitalsupplies.

POCDevelopment Services

Revenuerecognized under contracts for POC development services may, in some contracts, represent multiple performance obligations (wherepromises to the customers are distinct) in circumstances in which the work packages arenot interrelated or the customer is able to complete the services performed.

Forarrangements that include multiple performance obligations, the transaction price is allocated to the identified performance obligationsbased on their relative standalone selling prices.

Werecognize revenue when, or as, it satisfies a performance obligation. At contract inception, we determine whether the servicesare transferred over time or at a point in time. Performance obligations that have no alternative use and that we have the rightto payment for performance completed to date, at all times during the contract term, are recognized over time. All other Performanceobligations are recognized as revenues by the company at point of time (upon completion) .

Includedin POC development services is hospital supplies revenue which is derived principally from the sale or lease of productsand the performance of services to hospitals or other medical providers. Revenue is earned and recognized when product and servicesare received by the customer.

SignificantJudgement and Estimates

Significantjudgment is required to identifying the distinct performance obligations and estimating the standalone selling price ofeach distinct performance obligation, and identifying which performance obligations create assets with alternative use to us,which results in revenue recognized upon completion, and which performance obligations are transferred to the customer over time.

CellProcess Development Services (mainly discontinued operations)

Revenuerecognized under contracts for cell process development services may, in some contracts, represent multiple performance obligations(where promises to the customers are distinct) in circumstances in which the work packagesand milestones are not interrelated or the customer is able to complete the services performed independently or by using our competitors.In other contracts when the above circumstances are not met, the promises are not considered distinct and the contract representsone performance obligation. All performance obligations are satisfied over time, as there is no alternative use to theservices it performs, since, in nature, those services are unique to the customer, which retain the ownership of the intellectualproperty created through the process. Additionally, due to the non-refundable upfront payment the customer pays, together withthe payment term and cancellation fine, it has a right to payment (which include a reasonable margin), at all times, for workcompleted to date, which is enforceable by law.

Forarrangements that include multiple performance obligations, the transaction price is allocated to the identified performance obligationsbased on their relative standalone selling prices. For these contracts, the standalone selling prices are based on our normalpricing practices when sold separately with consideration of market conditions and other factors, including customer demographicsand geographic location.

Wemeasure the revenue to be recognized over time on a contract by contract basis, determining the use of eithera cost-based input method or output method, depending on whichever best depicts the transfer of control over the life of the performanceobligation.

TechTransfer Services (discontinued operations)

Revenuerecognized under contracts for tech transfer services are considered a single performance obligation, as all work packages (includingdata collection, GMP documentation, validation runs) and milestones are interrelated. Additionally, the customer is unable tocomplete services of work performed independently or by using our competitors. Revenue is recognized overtime using a cost-based input method where progress on the performance obligation is measured by the proportion of actual costsincurred to the total costs expected to complete the contract.

CellManufacturing Services (discontinued operations)

Revenuesfrom cell manufacturing services represent a singleperformance obligation which is recognized over time. The progress towards completion will continue to be measured on an outputmeasure based on direct measurement of the value transferred to the customer (units produced).

ReimbursedExpenses

Weinclude reimbursed expenses in revenues and costs of revenue as we are primarily responsible for fulfilling the promise to providethe specified service, including the integration of the related services into a combined output to the customer, which are inseparablefrom the integrated service. These costs include such items as consumable, reagents, transportation and travel expenses, overwhich we have discretion in establishing prices.

ChangeOrders

Changesin the scope of work are common and can result in a change in transaction price, equipment used and payment terms. Change ordersare evaluated on a contract-by-contract basis to determine if they should be accounted for as a new contract or as part of theexisting contract. Generally, services from change orders are not distinct from the original performance obligation. As a result,the effect that the contract modification has on the contract revenue, and measure of progress, is recognized as an adjustmentto revenue when they occur.

Costsof Revenue (Discontinued Operations)

Costsof revenue include (i) compensation and benefits for billable employees and personnel involved in production, data managementand delivery, and the costs of acquiring and processing data for our information offerings; (ii) costs of staff directly involvedwith delivering services offerings and engagements; (iii) consumables used for the services; and (iv) other expenses directlyrelated to service contracts such as courier fees, laboratory supplies, professional services and travel expenses.

ContractAssets and Liabilities

Contractassets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currentlydue from customers.

Theactivity for trade receivables is comprised of:

		Year Ended December 31,
		2020				2019
		(in thousands)
Balance as of beginning of period		$	1,831			$	129
Acquisition of Koligo			228				-
Additions			6,997				2,079
Collections			(5,982	)			(364	)
Exchange rate differences			11				(13	)
Balance as of end of period		$	3,085			$	1,831

Theactivity for contract liabilities is comprised of:

		Year Ended December 31,
		2020				2019
		(in thousands)
Balance as of beginning of period		$	325			$	56
Additions			597				1,126
Realizations			(862	)			(854	)
Exchange rate differences			(1	)			(3	)
Balance as of end of period		$	59			$	325

Seenote 2(z).

Seenote (x).

Seenote 2(y).

Off-BalanceSheet Arrangements

Wehave no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financialcondition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capitalresources that is material to stockholders.

ITEM7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Notapplicable.

ITEM8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Theinformation called for by Item 8 is included following the “Index to Financial Statements” on page F-1 contained inthis Annual Report on Form 10-K.

ITEM9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM9A. CONTROLS AND PROCEDURES

Evaluationof Disclosure Controls and Procedures

Ourmanagement, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectivenessof our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act andregulations promulgated thereunder) as of December31, 2020 , or the Evaluation Date. Based on such evaluation, our Chief Executive Officerand Chief Financial Officer have concluded that, as of the Evaluation Date, our disclosure controls and procedures are effective.

Management’sReport on Internal Control over Financial Reporting

Ourmanagement, under the supervision of the Chief Executive Officer and Chief Financial Officer ,is responsible for establishing and maintaining adequate internal control over financial reporting for our company. Internal controlover financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act as a process designed by,or under the supervision of, the company’s principal executive and principal financial officers and effected by the company’sboard of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reportingand the preparation of financial statements for external purposes in accordance with GAAP and includes those policies and proceduresthat: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions anddispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permitpreparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expendituresof our company are being made only in accordance with authorizations of management and directors of the company; and (iii) providereasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our company’sassets that could have a material effect on the financial statements.

TheKoligo acquisition which was completed in October 2020 was excluded from management’s evaluation of internal control overfinancial reporting as of December 31, 2020 because the business was acquired in a transaction accounted for as a business combinationduring 2020. Koligo, represents approximately 2% of our total consolidated assets and approximately 3% of our total consolidatedrevenues as of and for the year ended December 31, 2020.

Ourmanagement, with the participation of our Chief Executive Officer and Chief Financial Officer ,evaluated the effectiveness of our internal control over financial reporting as of December 31, 2020. In making this evaluation,our management used the criteria set forth in the Internal Control — Integrated Framework (2013) issued by the Committeeof Sponsoring Organizations of the Treadway Commission.

Basedon this evaluation, management concluded that our internal control over financial reporting was effective as of December 31, 2020based on those criteria.

Thisannual report does not include an attestation report of our registered public accounting firm on internal control over financialreporting because we are is a smaller reporting company and non-accelerated filer.

Changesin Internal Control Over Financial Reporting

Therewere no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2020 thathave materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

ITEM9B. OTHER INFORMATION

None.

PARTIII

ITEM10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Thefollowing table sets forth certain information regarding our each of our current Directors and Executive Officers as of March9, 2021.

Name		Age		Position
Vered Caplan		52		Chief Executive Officer and Chairperson of the Board of Directors
Neil Reithinger		51		Chief Financial Officer, Secretary and Treasurer
David Sidransky (1) (2) (4)		60		Director
Guy Yachin (1) (2) (3) (4)		53		Director
Yaron Adler (2) (3)		50		Director
Ashish Nanda (3)		55		Director
Mario Philips (1)		51		Director

(1)	A member on the audit committee.
(2)	A member on the compensation committee.
(3)	A member on the nominating and corporate governance committee.
(4)	A member of the research and development committee.

OurExecutive Officers

VeredCaplan – Chief Executive Officer and Chairperson of the Board of Directors

Ms.Caplan has served as our CEO and Chairperson of the Board of Directors since August 14, 2014, prior to which she served as InterimPresident and CEO commencing on December 23, 2013. She joined our Board of Directors in February 2012. She has 26 yearsof industry experience, previously holding positions as CEO of Kamedis Ltd. from2009 to 2014 , CEO of GammaCan International Inc. from 2004 to 2007. She also served as a director of the following companies:Opticul Ltd., Inmotion Ltd., Nehora Photonics Ltd., Ocure Ltd., Eve Medical Ltd., and Biotech Investment Corp. Ms. Caplan holdsa M.Sc. in biomedical engineering from Tel Aviv University specializing in signal processing; management for engineers from TelAviv University specializing in business development; and a B.Sc. in mechanical engineering from the Technion– Israel Instituteof Technology specialized in software and cad systems.

NeilReithinger – Chief Financial Officer, Secretary and Treasurer

Mr.Reithinger was appointed Chief Financial Officer, Secretary and Treasurer on August 1, 2014. Mr. Reithinger is the Founder andPresident of Eventus Advisory Group, LLC, a private, CFO-services firm incorporated in Arizona, which specializes in capital advisoryand SEC compliance for publicly-traded and emerging growth companies. He is also the President of Eventus Consulting, P.C., aregistered CPA firm in Arizona. Prior to forming Eventus, Mr. Reithinger was Chief Operating Officer & CFO from March 2009to December 2009 of New Leaf Brands, Inc., a branded beverage company, CEO of Nutritional Specialties, Inc. from April 2007 toOctober 2009, a nationally distributed nutritional supplement company that was acquired by Nutraceutical International, Inc.,Chairman, CEO, President and director of Baywood International, Inc. from January 1998 to March 2009, a publicly-traded nutraceuticalcompany and Controller of Baywood International, Inc. from December 1994 to January 1998. Mr. Reithinger earned a B.S. in Accountingfrom the University of Arizona and is a Certified Public Accountant. He is a Member of the American Institute of Certified PublicAccountants and the Arizona Society of Certified Public Accountants.

OurDirectors

Dr.David Sidransky – Director

Dr.Sidransky has served as a director since his appointment on July 18, 2013. Dr. Sidransky is a renowned oncologist and researchscientist named and profiled by TIME magazine in 2001 as one of the top physicians and scientists in America, recognized for hiswork with early detection of cancer. Since 1994, Dr. Sidransky has been the Director of the Head and Neck Cancer Research Divisionat Johns Hopkins University School of Medicine’s Department of Otolaryngology and Professor of Oncology, Cellular &Molecular Medicine, Urology, Genetics, and Pathology at the John Hopkins University School of Medicine. Dr. Sidransky is one ofthe most highly cited researchers in clinical and medical journals in the world in the field of oncology during the past decade,with over 560 peer reviewed publications. Dr. Sidransky is a founder of a number of biotechnology companies and holds numerousbiotechnology patents. Dr. Sidransky has served as Vice Chairman of the board of directors, and was, until the merger with EliLilly, a director of ImClone Systems, Inc., a global biopharmaceutical company committed to advancing oncology care. He is currentlyon the board of Directors of Galmed and Champions Oncology. and chairs the board of directors of Advaxis and Ayala . Dr. Sidranskyserved as Director from 2005 until 2008 of the American Association for Cancer Research (AACR). He was the chairperson of AACRInternational Conferences during the years 2006 and 2007 on Molecular Diagnostics in Cancer Therapeutic Development: MaximizingOpportunities for Personalized Treatment. Dr. Sidransky is the recipient of a number of awards and honors, including the 1997Sarstedt International Prize from the German Society of Clinical Chemistry, the 1998 Alton Ochsner Award Relating Smoking andHealth by the American College of Chest Physicians, and the 2004 Richard and Hinda Rosenthal Award from the American Associationof Cancer Research. Dr. Sidransky received his BS in Chemistry from Brandies University and his medical degree from Baylor Collegeof medicine where he also completed his residency in internal medicine. His specialty in Medical Oncology was completed at JohnsHopkins University and Hospital.

Webelieve Dr. Sidransky is qualified to serve on our Board of Directors because of his education, medical background, experiencewithin the life science industry and his business acumen in the public markets.

GuyYachin – Director

Mr.Yachin has served as a director since his appointment on April 2, 2012. Mr. Yachin has served as the President and CEO of SerpinPharma, a clinical stage Virginia-based company focused on the development of anti-inflammatory drugs, since April 2013. Mr. Yachinis the CEO of Oasis Management, a Maryland-based consulting company, since 2010. Mr. Yachin is the CEO of NasVax Ltd., a companyfocused on the development of improved immunotherapeutics and vaccines. Prior to joining NasVax, Mr. Yachin served as CEO of MultiGeneVascular Systems Ltd., a cell therapy company focused on blood vessels disorders, leading the company through clinical studiesin the U.S. and Israel, financial rounds, and a keystone strategic agreement with Teva Pharmaceuticals Industries Ltd. He wasCEO and founder of Chiasma Inc., a biotechnology company focused on the oral delivery of macromolecule drugs, where he built thecompany’s presence in Israel and the U.S., concluded numerous financial rounds, and guided the company’s strategyand operation for over six years. Earlier, he was CEO of Naiot Technological Center Ltd., and provided seed funding and guidanceto more than a dozen biomedical startups such as Remon Medical Technologies Ltd., Enzymotec Ltd. and NanoPass Technologies Ltd.He holds a BSc. in Industrial Engineering and Management and an MBA from the Technion – Israel Institute of Technology.Mr. Yachin served on the board of Peak Pharmaceuticals, Inc. from March 2014 to April 2016.

Webelieve Mr. Yachin is qualified to serve on our Board of Directors because of his education, experience within the life scienceindustry and his business acumen in the public markets.

YaronAdler – Director

Mr.Adler has served as a director since his appointment on April 17, 2012. Mr. Adler is the co-founder of a startup incubator, WeGroup Ltd. In 1999, Mr. Adler co-founded IncrediMail Ltd. and served as its CEO until 2008 and President until 2009. In 1999,prior to founding IncrediMail, Mr. Adler consulted Israeli startup companies regarding Internet products, services and technologies.Mr. Adler served as a product manager from 1997 to 1999, and as a software engineer from 1994 to 1997, at Tecnomatix TechnologiesLtd., a software company that develops and markets production engineering solutions to complex automated manufacturing lines thatfill the gap between product design and production, and which was acquired by UGS Corp. in April 2005. In 1993, Mr. Adler helda software engineer position at Intel Israel Ltd. He has a B.A. in computer sciences and economics from Tel Aviv University.

Webelieve Mr. Adler is qualified to serve on our Board of Directors because of his education, success with early-stage enterprisesand his business acumen in the public markets.

AshishNanda – Director

Mr.Nanda has served as a director since his appointment on February 22, 2017. Since 1998, Mr. Nanda has been the Managing Directorof Innovations Group, one of the largest outsourcing companies in the financial sector that employs close to 14,000 people workingacross various financial sectors. Since 1992, Mr. Nanda has served as the Managing Partner of Capstone Insurance Brokers LLC and,since 2009, has served as Managing Partner of Dive Tech Marine Engineering Services L.L.C. From 1991 to 1994, Mr. Nanda held theposition of Asst. Manager Corporate Banking at Emirates Banking Group where he was involved in establishing relationships withbusiness houses owned by UAE nationals and expatriates in order to set up banking limits and also where he managed portfoliosof USD $26 billion. Mr. Nanda holds a Chartered Accountancy from the Institute of Chartered Accountants from India.

Webelieve that Mr. Nanda is qualified to serve on our Board of Directors because of his business experience and strategic understandingof advancing the valuation of companies in emerging industries.

Thereare no family relationships between any of the above executive officers or directors or any other person nominated or chosen tobecome an executive officer or a director. Pursuant to an agreement entered into between us and Image Securities fzc. (“Image”),for so long as Image’s ownership of our company is 10% or greater, it was grantedthe right to nominate a director to our Board of Directors. Mr. Nanda was nominated for a directorship at the 2017 annual meetingin compliance with our contractual undertakings.

MarioPhilips – Director

Mr.Philips has served as a director since his appointment on January 9, 2020. Since November 2020, Mr. Philips has been Chief ExecutiveOfficer of Polyplus, a leading Biotech supplier of transfection reagents for cell & gene therapy as well as the research lifesciences market. Mario is also chairmen of the Board of PLL Therapeutics, a drug company based in France that has developed adiagnostic platform technology for neurodegenerative diseases in combination with a therapy to cure neurodegenerative diseasessuch as ALS and Parkinson’s.

Priorto that Mario acted as VP/GM for Danaher Pall Biotech business with full P&L responsibility for a $1,3B business unit. Mariojoined Pall in February 2014, as part of the Pall acquisition of ATMI Life Sciences, and was appointed to Vice President and GeneralManager to lead the Single-Use Technologies BU. In this role he was responsible for leading and executing an aggressive investmentand growth strategy.

Mariojoined ATMI in 1999 with ATMI’s acquisition of MST Analytics, Inc., serving as European Sales Manager for ATMI AnalyticalSystems. In 2004, Mario was appointed to General Manager of ATMI Packaging, a role he held through 2010 when he was promoted tothe position of Senior Vice President and General Manager, ATMI Life Sciences. In that role, he was responsible for developingand executing all business strategies, including the introduction of new products and service solutions for the Life Sciencesindustry. A strong leading innovative IP portfolio was created, Pall acquired the business in 2014.

Marioalso held in the past several board member positions in the life sciences industry with Clean Biologics, Austar Life Sciences(China), Disposable Lab (France) and Artelis (Belgium).

Webelieve that Mr. Philips is qualified to serve on our Board of Directors because of his business experience and strategic understandingof advancing the valuation of companies in emerging industries.

Boardof Directors

OurBoard of Directors currently consists of six (6) members. All directors hold office until the next annual meeting of stockholders.At each annual meeting of stockholders, the successors to directors whose terms then expire are elected to serve from the timeof election and qualification until the next annual meeting following election.

Managementhas been delegated the responsibility for meeting defined corporate objectives, implementing approved strategic and operatingplans, carrying on our business in the ordinary course, managing cash flow, evaluating new business opportunities, recruitingstaff and complying with applicable regulatory requirements. The Board of Directors exercises its supervision over managementby reviewing and approving long-term strategic, business and capital plans, material contracts and business transactions, andall debt and equity financing transactions and stock issuances.

DirectorIndependence

OurBoard of Directors is comprised of a majority of independent directors. In determining director independence, the Company usesthe definition of independence in Rule 5605(a)(2) of the listing standards of The Nasdaq Stock Market.

TheBoard has concluded that each of Dr. Sidransky, and Messrs. Yachin, Adler, Philips and Nanda is “independent” basedon the listing standards of the Nasdaq Stock Market, having concluded that any relationship between such director and our company,in its opinion, does not interfere with the exercise of independent judgment in carrying out the responsibilities of a director.

BoardCommittees

OurBoard of Directors has established an Audit Committee, a Compensation Committee and a Nominating and Corporate Governance Committee,with each comprised of independent directors in accordance with the rules of The Nasdaq Stock Market and applicable federal securitieslaws and regulations. The members of the Audit Committee are Dr. Sidransky and Messrs. Yachin and Philips. The members of theCompensation Committee are Dr. Sidransky and Messrs. Adler and Yachin. The members of the Nominating and Corporate GovernanceCommittee are Messrs. Nanda, Adler and Yachin. The members of the Research and Development Committee are Mr. Yachin and Dr. Sidransky.

Eachcommittee operates under a written charter that has been approved by our Board of Directors. Copies of our committee chartersare available on the investor relations section of our website, which is located at http://www.orgenesis.com.

AuditCommittee

TheAudit Committee (a) assists the Board of Directors in fulfilling its oversight of: (i) the quality and integrity of our financialstatements; (ii) our compliance with legal and regulatory requirements relating to our financial statements and related disclosures;(iii) the qualifications and independence of our independent auditors; and (iv) the performance of our independent auditors;and (b) prepares any reports that the rules of the SEC require be included in our proxy statement for our annual meeting.

TheAudit Committee held 9 meetings in fiscal 2020. In addition, the Audit Committee reviewed and approved various corporate itemsby way of written consent during the fiscal year 2020. The Board has determined that each member of the Audit Committee is anindependent director in accordance with the rules of The Nasdaq Stock Market and applicable federal securities laws and regulations.In addition, the Board has determined that Dr. Sidransky is an “audit committee financial expert” within the meaningof Item 407(d)(5) of Regulation S-K and has designated him to fill that role. See “Directors, Executive Officers and CorporateGovernance – Directors” above for descriptions of the relevant education and experience of each member of the AuditCommittee.

Atno time since the commencement of our most recently completed fiscal year was a recommendation of the Audit Committee to nominateor compensate an external auditor not adopted by the Board of Directors.

TheAudit Committee is responsible for the oversight of our financial reporting process on behalf of the Board of Directors and suchother matters as specified in the Audit Committee’s charter or as directed by the Board of Directors. Our Audit Committeeis directly responsible for the appointment, compensation, retention and oversight of the work of any registered public accountingfirm engaged by us for the purpose of preparing or issuing an audit report or performing other audit, review or attest servicesfor us (or to nominate the independent registered public accounting firm for stockholder approval), and each such registered publicaccounting firm must report directly to the Audit Committee. Our Audit Committee must approve in advance all audit, review andattest services and all non-audit services (including, in each case, the engagement and terms thereof) to be performed by ourindependent auditors, in accordance with applicable laws, rules and regulations.

CompensationCommittee

TheCompensation Committee (i) assists the Board of Directors in discharging its responsibilities with respect to compensation ofour executive officers and directors, (ii) evaluates the performance of our executive officers, and (iii) administers our stockand incentive compensation plans and recommends changes in such plans to the Board as needed.

TheCompensation Committee acted by unanimous written consent or held 5 meetings in fiscal 2020. In addition, the Compensation Committeereviewed and approved various corporate items by way of written consent during the fiscal year 2019. The Board of Directors hasdetermined that each member of the Compensation Committee is an independent director in accordance with the rules of The NasdaqStock Market and applicable federal securities laws and regulations.

Nominatingand Corporate Governance Committee

TheNominating and Corporate Governance Committee assists the Board in (i) identifying qualified individuals to become directors,(ii) determining the composition of the Board and its committees, (iii) developing succession plans for executive officers, (iv)monitoring a process to assess Board effectiveness, and (v) developing and implementing our corporate governance procedures andpolicies.

TheNominating and Corporate Governance Committee acted by unanimous written consent or held 4 meeting in fiscal 2020. The Board hasdetermined that each member of the Nominating and Corporate Governance Committee is an independent director in accordance withthe rules of The Nasdaq Stock Market and applicable federal securities laws and regulations.

Researchand Development Committee

TheResearch and Development Committee assists the Board in fulfilling the Board’s responsibilities to oversee the Company’sresearch and development programs, and strategies.

TheResearch and Development Committee was established in January 2021. The Board has determined that each member of the Researchand Development Committee is an independent director in accordance with the rules of The Nasdaq Stock Market and applicable federalsecurities laws and regulations.

DELINQUENTSECTION 16(a) REPORTS

Section16(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), requires officers and directors ofthe Company and persons who beneficially own more than ten percent (10%) of the Common Stock outstanding to file initial statementsof beneficial ownership of Common Stock (Form 3) and statements of changes in beneficial ownership of Common Stock (Forms 4 or5) with the SEC. Officers, directors and greater than 10% stockholders are required by SEC regulation to furnish us with copiesof all such forms they file.

Ourrecords reflect that all reports which were required to be filed pursuant to Section 16(a) of the Securities Exchange Act of 1934,as amended, were filed on a timely basis, except that two reports, covering an aggregate of five transactions, were filed lateby David Sidransky, one report, covering an aggregate of one transaction, was filed late by Yaron Adler, one report, coveringan aggregate of one transaction, was filed late by Guy Yachin, and one report, covering an aggregate of one transaction, was filedlate by Ashish Nanda.

CorporateCode of Conduct and Ethics

OurBoard of Directors has adopted a written code of business conduct and ethics that applies to our directors, officers and employees,including our principal executive officer, principal financial officer, principal accounting officer or controller, or personsperforming similar functions. Copies of our corporate code of conduct and ethics are available, without charge, upon request inwriting to Orgenesis Inc., 20271 Goldenrod Lane, Germantown, MD, 20876, Attn: Secretary and are posted on the investor relationssection of our website, which is located at www.orgenesis.com. The inclusion of our website address in this Annual Report on Form10-K does not include or incorporate by reference the information on our website into this Annual Report on Form 10-K. We alsointend to disclose any amendments to the Corporate Code of Conduct and Ethics, or any waivers of its requirements, on our website.

ITEM11. EXECUTIVE COMPENSATION

Thefollowing table shows the total compensation paid or accrued during the last two fiscal years ended December 31, 2020 to our ChiefExecutive Officer and Chief Financial Officer. As of December 31, 2020, there were no other executive officers who earnedmore than $100,000 during the fiscal year ended December 31, 2020 and were serving as executive officers as of such date (the“named executive officers”).

SummaryCompensation Table

Name and Principal Position		Year				Salary ($)				Bonus ($)				Stock Awards ($)				Option Awards ($) (1)				Non-Equity Incentive Plan Compensa- tion ($)				Non-qualified Deferred Compensation Earnings ($)				All Other Compensa- tion ($) (2)				Total ($)
Vered Caplan			2020				250,000				400,000				-				163,239				-				-				215,640				1,028,879
CEO(3)			2019				250,000				200,000				-				871,036				-				-				77,020				1,398,056
Neil Reithinger CFO, Treasurer &			2020				255,231				200,000				-				57,331				-				-				-				512,562
Secretary			2019				213,653				-				-				22,970				-				-				-				236,623

(1)	In accordance with SEC rules, the amounts in this column reflect the fair value on the grant date of the option awards granted to the named executive, calculated in accordance with ASC Topic 718. Stock options were valued using the Black-Scholes model. The grant-date fair value does not necessarily reflect the value of shares which may be received in the future with respect to these awards. The grant-date fair value of the stock options in this column is a non-cash expense for the Company that reflects the fair value of the stock options on the grant date and therefore does not affect our cash balance. The fair value of the stock options will likely vary from the actual value the holder receives because the actual value depends on the number of options exercised and the market price of our Common Stock on the date of exercise. For a discussion of the assumptions made in the valuation of the stock options, see Note 15 to this Annual Report on Form 10-K for the year ended  December 31, 2020.
(2)	For 2020 and 2019, represents the compensation as described under the caption “All Other Compensation” below.

AllOther Compensation

Thefollowing table provides information regarding each component of compensation for fiscal years 2020 and 2019 included in the AllOther Compensation column in the Summary Compensation Table above. Represents amounts paid in New Israeli Shekels (NIS) or SwissFranks and converted at average exchange rates for the year.

Name		Year				Automobile and Communication Related Expenses $ (1)				Social Benefits $ (2)				Total $
Vered Caplan			2020				13,172				202,468				215,640
			2019				18,876				58,144				77,020

(1)	Represents for Ms. Caplan, a leased automobile and communication expenses.
(2)	These are comprised of contributions by the Company to savings, severance, pension, disability and insurance plans generally provided in Israel and Switzerland, including education funds and managerial insurance funds, and redeemed vacation pay. This amount represents Israeli and Swiss severance fund payments, managerial insurance funds, disability insurance, supplemental education fund contribution and social securities. See discussion below under “Narrative Disclosure to Summary Compensation Table – Vered Caplan.”

OutstandingEquity Awards at December 31, 2020

Thefollowing table summarizes the outstanding equity awards held by each named executive officer of our company as of December 31,2020.

Name		Grant Date		Number of Shares Underlying Unexercised Options (#) Exercisable				Number of Shares Underlying Unexercised Options (#) Unexercisable				Option Exercise Price ($)				Option Expiration Date
Vered Caplan		02-Feb-12 (1)			278,191				-				0.012			02-Feb-22
		22-Aug-14 (1)			230,189				-				0.0012			22-Aug-24
		09-Dec-16 (1)			166,667				-				4.80			09-Dec-26
		06-Jun-17 (1)			83,334				-				7.20			06-Jun-27
		28-Jun-18 (1)			250,000				-				8.36			28-Jun-28
		22-Oct-18 (3)			42,500				42,500				5.99			22-Oct-28
		19-Mar-20 (2)			31,875				53,125				2.99			18-Mar-30
Neil Reithinger		09-Dec-16 (1)			83,334				-				4.80			09-Dec-26
		08-Mar-19 (2)			6,250				18,750				5.07			08-Mar-29
		19-Mar-20 (2)			5,625				9,375				2.99			18-Mar-30

(1)	The options were fully vested as of December 31, 2020 .
(2)	The options vest on a quarterly basis over a period of two years from the date of grant.
(3)	The options vest on a quarterly basis over a period of four years from the date of grant.

Therewere no option exercises by our named executive officers during our fiscal year ended December 31, 2019 and 2020.

NarrativeDisclosure to Summary Compensation Table

VeredCaplan

OnAugust 14, 2014, our Board of Directors confirmed that Ms. Vered Caplan, who had served as our President and Chief Executive Officeron an interim basis since December 23, 2013, was appointed as our President and Chief Executive Officer.

OnMarch 30, 2017, we and Ms. Caplan entered into an employment agreement replacing a previous employment agreement dated August22, 2014 (the “Amended Caplan Employment Agreement”). Under the Amended Caplan Employment Agreement, which took effectApril 1, 2017, Ms. Caplan’s annual salary continued at $160,000 per annum, subject to adjustment to $250,000 per annum uponthe listing of the Company’s securities on an Exchange. On May 10, 2017, we and Ms. Caplan further amended the Amended CaplanEmployment Agreement pursuant to which Ms. Caplan became entitled to a grant under the 2017 of options (the “Initial Option”)to purchase 83,334 shares of the Company’s common stock at a per share exercise price equal to the Fair Market Value (asdefined in our 2017 Equity Incentive Plan (the “2017 Plan”)) of the Company’s common stock on the date of grant.The amendment further provided that beginning in fiscal 2018, subject to approval by the compensation committee, Ms. Caplan becameentitled to an additional option (the “Additional Option”; together with the Initial Option, the “Options”)under the 2017 Plan for up to 250,000 shares of common stock of the Company to be awarded in such amounts per fiscal year as shallbe consistent with the Plan, in each case at a per share exercise price equal to the Fair Market Value (as defined in the Plan)of the Company’s common stock on the date of grant. In 2018, following the listing of the Company’s securities onNasdaq, Ms. Caplan’s annual salary was raised to $250,000.

Foradditional information regarding Ms. Caplan’s stock options awards, see the Outstanding Equity Awards table above.

OnNovember 19, 2020, we and Ms. Caplan entered into an executive directorship agreement, effective as of October 1, (the “ExecutiveDirectorship Agreement”), that supersedes and replaces the Amended Caplan Employment Agreement (the “Prior Agreement”).Pursuant to the Executive Directorship Agreement, Ms. Caplan will continue to serve the Company as its Chairperson of the Boardof Directors (the “Board”) and shall receive in consideration for her serving as Chairperson of the Board an annualregular Board fee in the amount of $75,000 payable by the Company in equal quarterly installments in advance. In addition, Ms.Caplan may be eligible for non-recurring special Board fees as reviewed and approved by the Compensation Committee of the Board(the “Compensation Committee”) and then reviewed and ratified by the Board. In addition, Ms. Caplan may be grantedoption awards from time to time at the discretion of the Compensation Committee.

Ms.Caplan’s position as Chairperson of the Board under the Executive Directorship Agreement may be terminated for any reasonby either Ms. Caplan or the Company upon 90 days prior written notice (the “Notice Period”), provided that the Companymay terminate such appointment as Chairperson at any time during the Notice Period subject to certain conditions. Such terminationas Chairperson of the Board will be deemed a termination even if Ms. Caplan remains as a regular director of the Board. Upon terminationby the Company of Ms. Caplan’s employment other than for cause or by Ms. Caplan for any reason whatsoever, in addition toany Accrued Obligations (as defined therein) she shall be entitled to receive a lump sum payment equal to the sum of (i) the annualregular Board fee (the “Board Fee”) and (ii) the greater of actual or target annual performance bonus to which shemay have been entitled to as of the termination date (in each case, less all customary and required taxes and related deductions).

Ms.Caplan’s position under the Executive Directorship Agreement may be terminated in the event of a Change of Control (as definedtherein) by the Company other than for cause or by Ms. Caplan for any reason whatsoever. In the event of a Change of Control andif, within one year following such Change of Control, employment under the Executive Directorship Agreement is terminated by theCompany other than for cause or by Ms. Caplan for any reason whatsoever, in addition to any Accrued Obligations, she shall beentitled to receive a lump sum payment equal to one and a half times the sum of (i) the Board Fee and (ii) the target annual performanceremuneration to which she may have been entitled as of the termination date (in each case, less all customary and required taxesand related deductions).

Inaddition, on November 19, 2020, Orgenesis Services Sàrl, a Swiss corporation and wholly-owned, direct subsidiary of theCompany (“Orgenesis Services”), and Ms. Caplan entered into a personal employment agreement (the “Swiss EmploymentAgreement” and together with the Executive Directorship Agreement, the “Agreements”), pursuant to which Ms.Caplan will serve as Chief Executive Officer, President and Chairperson of the Board of Directors of Orgenesis Services and willbe a material provider of services to the Company pursuant to a services agreement between the Company and Orgenesis Services.The Swiss Employment Agreement provides that Ms. Caplan is entitled to a monthly base salary of CHF 13,345.05 (equivalent to $14,583based on the current exchange rate at signing), and an annual representation fee of CHF 24,000 (equivalent to $26,226 based onthe current exchange rate at signing), payable in monthly installments of CHF 2,000. Ms. Caplan is eligible to receive a bonusat the absolute discretion of Orgenesis Services and its compensation committee. Ms. Caplan may also be granted option awardsfrom time to time, as per the recommendation of the compensation committee of Orgenesis Services as reviewed and approved by theCompensation Committee. Under the Swiss Employment Agreement, Ms. Caplan is entitled to paid annual vacation days, monthly travelallowance, sick leave, expenses reimbursement and a mobile phone. The Swiss Employment Agreement has an effective date as of October1, 2020.

Employmentunder the Swiss Employment Agreement may be terminated for any reason by Ms. Caplan or by Orgenesis Services other than for justcause (as defined therein) upon six months prior written notice or by Orgenesis Services other than for just cause in the eventof a Change of Control (as defined therein) of the Company upon at least 12 months prior written notice. Upon termination by OrgenesisServices of Ms. Caplan’s employment without just cause or by Ms. Caplan for any reason whatsoever, in addition to any AccruedObligations (as defined therein), she shall be entitled to receive a lump sum payment equal to the sum of (i) her Base Salary(as defined therein) at the rate in effect as of the termination date and (ii) the greater of actual or target annual performancebonus to which she may have been entitled to for the year in which employment terminates (in each case, less all customary andrequired taxes and employment-related deductions). In the event of a Change of Control and if, within one year following suchChange of Control, employment is terminated by Orgenesis Services other than for cause or by Ms. Caplan for any reason whatsoever,in addition to any Accrued Obligations she shall be entitled to receive a lump sum payment equal to one and a half times the sumof (i) her Base Salary and (ii) the target annual performance bonus to which she may have been entitled to for the year in whichemployment terminates (in each case, less all customary and required taxes and employment-related deductions).

TheSwiss Employment Agreement provides for customary protections of Orgenesis Services’ confidential information and intellectualproperty.

OnNovember 19, 2020, the Compensation Committee approved a special remuneration of $400,000 to Ms. Caplan for her outstanding servicein the business development of the Company and its affiliates. The payment of such remuneration was made at the time of entryinto the Agreements.

NeilReithinger

Mr.Reithinger was appointed Chief Financial Officer, Treasurer and Secretary on August 1, 2014. Mr. Reithinger’s employmentagreement stipulates a monthly salary of $1,500; payment of an annual bonus as determined by the Company in its sole discretion,participation in the Company’s pension plan; grant of stock options as determined by the Company; and reimbursement of expenses.In addition, on August 1, 2014, the Company entered into a financial consulting agreement with Eventus Consulting, P.C., an Arizonaprofessional corporation, of which Mr. Reithinger is the sole shareholder (“Eventus”), pursuant to which Eventus hasagreed to provide financial consulting services to the Company. In consideration for Eventus’ services, the Company agreedto pay Eventus according to its standard hourly rate structure. The term of the consulting agreement was for a period of one yearfrom August 1, 2014 and automatically renews for additional one-year periods upon the expiration of the term unless otherwiseterminated. Eventus is owned and controlled by Mr. Reithinger. On December 16, 2020, the Compensation Committee of the Board ofDirectors of the Company, approved a special one-time bonus of $200,000 was paid prior to December 31, 2020. As of December 31,2020, Eventus was owed $28 thousand for accrued and unpaid services under the financial consulting agreement.

PotentialPayments upon Change of Control or Termination following a Change of Control

Ouremployment agreements with our named executive officers provide incremental compensation in the event of termination, as describedherein. Generally, we currently do not provide any severance specifically upon a change in control nor do we provide for acceleratedvesting upon change in control. Termination of employment also impacts outstanding stock options.

Dueto the factors that may affect the amount of any benefits provided upon the events described below, any actual amounts paid orpayable may be different than those shown in this table. Factors that could affect these amounts include the basis for the termination,the date the termination event occurs, the base salary of an executive on the date of termination of employment and the priceof our common stock when the termination event occurs.

Thefollowing table sets forth the compensation that would have been received by each of the Company’s executive officers hadthey been terminated as of December 31, 2020.

Name		Salary Continuation
Vered Caplan		$	*

(*)Termination by Company without cause: $250,000

Terminationwithout cause following a change in control: $375,000

DirectorCompensation

Thefollowing table sets forth for each non-employee director that served as a director during the year ended December 31, 2020 certaininformation concerning his or her compensation for the year ended December 31, 2020 and the December 2018 transition period:

YearEnded December 31, 2020

Name		Fees Earned or Paid in Cash ($)				Stock Awards ($)				Option Awards ($) (1)		Non-equity Incentive Plan Compensation ($)				Nonqualified Deferred Compensation Earnings ($)				All Other Compensation ($)				Total ($)
Guy Yachin			52,500				-			45,462 (2)			-				-				-				97,962
Yaron Adler			46,250				-			45,306 (3)			-				-				-				91,556
Dr. David Sidransky			75,000				-			45,518 (4)			-				-				-				120,518
Ashish Nanda			52,500				-			45,257 (5)			-				-				-				97,757
Mario Philips			37,500							27,514 (6)															65,014

(1)	In accordance with SEC rules, the amounts in this column reflect the fair value on the grant date of the option awards granted to the named executive, calculated in accordance with ASC Topic 718.  Stock options were valued using the Black-Scholes model.  The grant-date fair value does not necessarily reflect the value of shares which may be received in the future with respect to these awards.  The grant-date fair value of the stock options in this column is a non-cash expense for the Company that reflects the fair value of the stock options on the grant date and therefore does not affect our cash balance.  The fair value of the stock options will likely vary from the actual value the holder receives because the actual value depends on the number of options exercised and the market price of our common stock on the date of exercise.  For a discussion of the assumptions made in the valuation of the stock options, see Note 15 (Stock Based Compensation) to our financial statements, which are included in this Annual Report on Form 10-K.
(2)	Aggregate number of option awards outstanding as of December 31, 2020 was 150,934 of which (i) 122,184 options are exercisable as of December 31, 2020, (ii) 12,500 options are exercisable on April 1, 2021 and (iii) 16,250 options are exercisable on December 17, 2021. Does not include $192 thousand related to options held by Caerus Therapeutics LLC over which Mr. Yachin does not have beneficial control.
(3)	Aggregate number of option awards outstanding as of December 31, 2020 was 169,325 of which (i) 141,825 options are exercisable as of December 31, 2020, (ii) 12,500 options are exercisable as of April 1, 2021 and (iii) 15,000 options are exercisable on December 17, 2021.
(4)	Aggregate number of option awards outstanding as of December 31, 2020 was 133,401 of which (i) 104,201 options are exercisable as of December 31, 2020, (ii) 12,500 options are exercisable on April 1, 2021 and (iii) 16,700 options are exercisable on December 17, 2021.
(5)	Aggregate number of option awards outstanding as of December 31, 2020 was 66,700 of which (i) 39,600 options are exercisable as of December 31, 2020, (ii) 12,500 options are exercisable on April 1, 2021 and (ii) 14,600 options are exercisable on December 17, 2021.
(6)	Aggregate number of option awards outstanding as of December 31, 2020 was 32,500 of which (i) 2,083 options are exercisable on January 9, 2021 (ii) 12,500 options are exercisable on April 1, 2021 (iii) 13,750 options are exercisable on December 17, 2021 (iv) 2,084 options are exercisable on January 9, 2022 and (v) 2,084 options are exercisable on January 9, 2023.

Alldirectors receive reimbursement for reasonable out of pocket expenses in attending Board of Directors meetings and for participatingin our business.

CompensationPolicy for Non-Employee Directors.

InOctober 2018, the Board of Directors adopted a compensation policy for non-employee directors which replaced the non-employeedirector compensation terms discussed above. By its terms, the policy became effective November 2018. Under the adopted policy,each director is to receive an annual cash compensation of $30,000 and the Chairman and Vice Chairman is paid an additional $15,000per annum. Each committee member will be paid an additional $7,500 per annum and each committee chairman is to receive $15,000per annum. Cash compensation will be made on a quarterly basis.

Allnewly appointed directors also receive options to purchase up to 6,250 shares of the Company’s common stock. All directorsare entitled on an annual bonus of options for 12,500 shares and each committee member is entitled to a further option to purchaseup to 1,250 shares of common stock and each committee chairperson to options for an additional 2,100 shares of common stock. Inaddition, the Chairman and Vice Chairman shall be granted an option to purchase 4,200 shares of the Company’s ordinary shares.In all cases, the options are granted at a per share exercise price equal to the closing price of the Company’s publiclytraded stock on the date of grant and the vesting schedule is determined by the compensation committee at the time of grant.

CompensationCommittee Interlocks and Insider Participation

Noneof our executive officers has served as a member of the Board of Directors, or as a member of the compensation or similar committee,of any entity that has one or more executive officers who served on our Board of Directors or Compensation Committee during thefiscal year ended December 31, 2020.

ITEM12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

Thefollowing table sets forth certain information with respect to the beneficial ownership of our common stock as of March 9, 2021for (a) the named executive officers, (b) each of our directors, (c) all of our current directors and executive officers as agroup and (d) each stockholder known by us to own beneficially more than 5% of our common stock. Beneficial ownership is determinedin accordance with the rules of the SEC and includes voting or investment power with respect to the securities. We deem sharesof common stock that may be acquired by an individual or group within 60 days of March 9, 2021 pursuant to the exercise of optionsor warrants to be outstanding for the purpose of computing the percentage ownership of such individual or group but are not deemedto be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. Except as indicatedin footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power with respectto all shares of common stock shown to be beneficially owned by them based on information provided to us by these stockholders.Percentage of ownership is based on 24,199,674 shares of common stock outstanding on March 9, 2021.

SecurityOwnership of Greater than 5% Beneficial Owners

Name and Address of Beneficial Owner		Amount and Nature of Beneficial Ownership (1)				Percent (1)
Image Securities fzc. 2310, 23rd floor, Tiffany Towers, JLT Dubai, UAE			3,126,434	(2)			12.92	%
Yehuda Nir c/o Orgenesis Inc. 20271 Goldenrod Lane Germantown, MD 20876			2,175,152	(3)			8.99	%
Gakasa Holding, LLC c/o Knoll Capital Management 5 East 44th Street New York, NY 10017			1,316,364	(4)			5.44	%

SecurityOwnership of Directors and Executive Officers

Name and Address of Beneficial Owner		Amount and Nature of Beneficial Ownership (1)				Percent (1)
Vered Caplan c/o Orgenesis Inc. 20271 Goldenrod Lane Germantown, MD 20876			1,104,006	(5)			4.56	%
Neil Reithinger 14201 N. Hayden Road, Suite A-1 Scottsdale, AZ 85260			112,709	(6)			<1	%
Guy Yachin c/o Orgenesis Inc. 20271 Goldenrod Lane Germantown, MD 20876			134,684	(7)			<1	%
Dr. David Sidransky c/o Orgenesis Inc. 20271 Goldenrod Lane Germantown, MD 20876			116,701	(8)			<1	%
Yaron Adler c/o Orgenesis Inc. 20271 Goldenrod Lane Germantown, MD 20876			217,629	(9)			<1	%
Ashish Nanda c/o Orgenesis Inc. 20271 Goldenrod Lane Germantown, MD 20876			52,100	(10)			<1	%
Mario Philips c/o Orgenesis Inc. 20271 Goldenrod Lane Germantown, MD 20876			14,583	(11)			<1	%
Directors & Executive Officers as a Group (7 persons)			1,752,412				7.24	%

Notes:

(1)	Percentage of ownership is based on 24,167,784 shares of our common stock outstanding as of March 9, 2021.  Except as otherwise indicated, we believe that the beneficial owners of the common stock listed above, based on information furnished by such owners, have sole investment and voting power with respect to such shares, subject to community property laws where applicable.  Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities.  Shares of common stock subject to options or warrants currently exercisable or exercisable within 60 days, are deemed outstanding for purposes of computing the percentage ownership of the person holding such option or warrants but are not deemed outstanding for purposes of computing the percentage ownership of any other person.
(2)	Consists of (i) 1,494,217 ordinary shares and (ii) 1,832,538 ordinary shares issuable upon exercise of outstanding warrants at a price of $6.24 per share. The warrants are exercisable over a three-year period from the date of issuance.
(3)	Consists of (i) 309,464 ordinary shares issuable upon exercise of outstanding warrants at a price of $6.24 per share, exercisable until June 30, 2021, (ii) 153,846 ordinary shares issuable upon exercise of outstanding warrants at a price of $6.24 per share, exercisable until June 9, 2021, (iii) 50,000 ordinary shares issuable upon exercise of outstanding warrants at a price of $7.00 per share, exercisable until October 3, 2022, and (iv) 1,661,842 ordinary shares issuable upon exercise of convertible debt at a price of $7.00 per share.
(4)	Consists of 1,316,364 ordinary share s.

(5)	Consists of (i) 278,191 ordinary shares issuable upon exercise of outstanding options at a price of $0.012 per share, ( ii ) 230,189 ordinary shares issuable upon exercise of outstanding options at a price of $0.0012 per share, (iii) 166,667 ordinary shares issuable upon exercise of outstanding options at a price of $4.80 per share, (iv) 83,334 ordinary shares issuable upon exercise of outstanding options at a price of $7.20 per share, (vi) 250,000 ordinary shares issuable upon exercise of outstanding options at a price of $8.36 per share and (v) 53,125 ordinary shares issuable upon exercise of outstanding options at a price of $5.99 per share and(vii) 42,500 ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share. Does not include (i) options for 31,875 shares of common stock with an exercise price of $5.99 per share that are exercisable quarterly after April 22, 2021 and (ii) option for 42,500 shares of common stock with an exercise price of $2.99 per share that are exercisable quarterly after March 31, 2021.
(6)	Consists of (i) 83,334 ordinary shares issuable upon exercise of outstanding options at a price of $4.80 per share a nd (ii) 21,875 ordinary shares issuable upon exercise of outstanding options at a price of $5.07 per share (iii) 7,500 ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share. Does not include (i) options for 3,125 shares of common stock with an exercise price of $5.07 per share that are exercisable quarterly after April 1, 2021 and (ii) option for 7,500 shares of common stock with an exercise price of $2.99 per share that are exercisable quarterly after March 31, 2021.
(7)	Consists of (i) 39,267 ordinary shares issuable upon exercise of outstanding options at a price of $10.2 per share and (ii) 41,667 ordinary shares issuable upon exercise of outstanding options at a price of $4.80 per share and (iii) 28,750 ordinary shares issuable upon exercise of outstanding options at a price of $5.99 per share and (iv) 25,000 ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share. Does not include options exercisable at a price per share of $7.00 into 70,000 ordinary shares held by Caerus Therapeutics LLC for which Mr. Yachin does not have beneficial control.
(8)	Consists of (i) 20,834 ordinary shares issuable upon exercise of outstanding options at a price of $9 per share and (ii) 41,667 ordinary shares issuable upon exercise of outstanding options at a price of $4.80 per share and (iii) 29,200 ordinary shares issuable upon exercise of outstanding options at a price of $5.99 per share and (iv) 25,000 ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share.
(9)	Consists of (i) 63,304 ordinary shares, (ii) 58,908 ordinary shares issuable upon exercise of outstanding options at a price of $9.48 per share and (iii) 41,667 ordinary shares issuable upon exercise of outstanding options at a price of $4.80 per share and (iv) 28,750 ordinary shares issuable upon exercise of outstanding options at a price of $5.99 per share and (iiv) 25,000 ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share.
(10)	Consists of (i) 27,100 ordinary shares issuable upon exercise of outstanding options at a price of $5.99 per share and (ii) 25,000 ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share.
(11)	Consists of (i) 2,083 ordinary shares issuable upon exercise of outstanding options at a price of $4.7 per share and (ii) 12,500 ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share. Does not include options for 4,167 shares of common stock with an exercise price of $4.70 per share that are exercisable in three equal instalments over three anniversaries starting on January 9, 2022.

SecuritiesAuthorized for Issuance Under Existing Equity Compensation Plans

Thefollowing table summarizes certain information regarding our equity compensation plans as of December 31, 2020:

Plan Category		Number of Securities to be Issued Upon Exercise of Outstanding Options				Weighted-Average Exercise Price of Outstanding Options				Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a))
		(a)				(b)				(c)
Equity compensation plans approved by security holders (1)			2,503,002			$	4.64				1,496,998
Equity compensation plans not approved by security holders			963,806			$	3.55				141,668
Total			3,466,808			$	4.34				1,638,666

(1)	Consists of the 2017 Equity Incentive Plan and the Global Share Incentive Plan (2012). For a short description of those plans, see Note 15 to our 2020 Consolidated Financial Statements included in this Annual Report on Form 10-K for the year ended December 31, 2020.

ITEM13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Transactionswith Related Persons

Exceptas set out below, as of December 31, 2020, there have been no transactions, or currently proposed transactions, in which we wereor are to be a participant and the amount involved exceeds the lesser of $120,000 or one percent of the average of our total assetsat year-end for the last two completed fiscal years, and in which any of the following persons had or will have a direct or indirectmaterial interest:

●	any director or executive officer of our company;

●	any person who beneficially owns, directly or indirectly, shares carrying more than 5% of the voting rights attached to our outstanding shares of common stock;

●	any promoters and control persons; and

●	any member of the immediate family (including spouse, parents, children, siblings and in laws) of any of the foregoing persons.

OnSeptember 15, 2014, the Company received a loan in the principal amount of $100,000 from Yaron Adler Investments (1999) Ltd.,an entity of which Mr. Yaron Adler, one of the Company’s non-employee director, is the sole shareholder. The loan, withan original interest rate of 6% per annum, was repayable on or before March 15, 2015. The Loan currently bears a default interestrate of 24% per annum and, as of November 30, 2017, the outstanding balance on the note was $166,581. The loan was converted intoour common stock in 2018.

InJanuary 2017, the Company entered into definitive agreements with Image Securities fzc. (“Image”) for the privateplacement of 2,564,115 units of the Company’s securities for aggregate subscription proceeds to the Company of $16 millionat $6.24 price per unit. In July 2018, the Company entered into definitive agreements with assignees of Image whereby these assigneesremitted $4.6 million in respect of the units available under the original subscription agreement that have not been subscribedfor, entitling such investors to 702,307 units, with each unit being comprised of (i) one share of the Company’s commonstock and (ii) one three-year warrant to purchase up to an additional one share of the Company’s common stock at a per shareexercise price of $6.24.

InJuly 2018, the Company entered into definitive agreements with assignees of Image whereby these assignees remitted $4.6 millionin respect of the units available under the original subscription agreement that have not been subscribed for, entitling suchinvestors to 702,307 units, with each unit being comprised of (i) one share of the Company’s common stock and (ii) one three-yearwarrant to purchase up to an additional one share of the Company’s common stock at a per share exercise price of $6.24.

During2018, the Company raised $6.9 million from Image entitling it to 1,111,380 shares of Common Stock and three-year warrants foran additional 1,111,380 shares of the Company’s Common Stock at a per share exercise price of $6.24. Following this remittanceand those referred to in the previous paragraph, the Company received a total of $16 million out of the committed $16 millionsubscription proceeds under such agreement

Pursuantto an agreement entered into between the Company and Image, so long as Image’s ownershipof the company is 10% or greater, it is entitled to nominate a director to the Company’s Board of Directors. Mr.Nanda was nominated for a directorship at the 2018 annual meeting in compliance with our contractual undertakings.

Pursuantto our Audit Committee charter adopted in March 2017, the Audit Committee is responsible for reviewing and approving, prior toour entry into any such transaction, all transactions in which we are a participant and in which any parties related to us haveor will have a direct or indirect material interest.

Pursuant toagreements with Image, the Company procured services from Image in the amount of $4.8 million during the year ended December 31,2020, and earned revenues from Image in the amount of $1.5 million and $1.3 million for the years ended December 31, 2020and December 31, 2019, respectively. In addition, the company earned interest income in the amount of $169 thousandand $112 thousand for the years ended December 31, 2020 and December 31, 2019, respectively.

NamedExecutive Officers and Current Directors

Forinformation regarding compensation for our named executive officers and current directors, see “Executive Compensation.”

DirectorIndependence

See“Directors, Executive Officers and Corporate Governance – Director Independence” and “Directors, ExecutiveOfficers and Corporate Governance – Board Committees” in Item 10 above.

ITEM14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

TheBoard of Directors of the Company has appointed Kesselman & Kesselman, a memberfirm of PricewaterhouseCoopers International Limited (“PwC”) as our independent registered public accounting firm(the “Independent Auditor”) for the fiscal year end ed December 31, 2020.The following table sets forth the fees billed to the Company for professional services rendered by PwC for the years ended December31, 2020 and December 31, 2019:

		Year Ended December 31,
Services:		2020				2019
Audit Fees (1)		$	267,231			$	426,040
Audit-Related Fees (2)			67,405				26,900
Tax Fees (3)			12,500				18,300
All Other Fees			10,000				49,500
Total fees		$	357,136			$	520,740

(1)

Audit fees consisted of audit work performed in the preparation of financial statements, as well as work generally only the independent registered public accounting firm can reasonably be expected to provide, such as statutory audits.

	(2)	Audit related fees consisted principally of audits of employee benefit plans and special procedures related to regulatory filings in 2020.
	(3)	The tax fees were paid for reviewing various tax related matters.

Policyon Audit Committee Pre-Approval of Audit and Permissible Non-audit Services of Independent Public Accountant

Consistentwith SEC policies regarding auditor independence, the Audit Committee has responsibility for appointing, setting compensationand overseeing the work of our independent registered public accounting firm. In recognition of this responsibility, the AuditCommittee has established a policy to pre-approve all audit and permissible non-audit services provided by our independent registeredpublic accounting firm.

Priorto engagement of an independent registered public accounting firm for the next year’s audit, management will submit an aggregateof services expected to be rendered during that year for each of four categories of services to the Audit Committee for approval.

1. Audit services include audit work performed in the preparation of financial statements, as well as work that generallyonly an independent registered public accounting firm can reasonably be expected to provide, including comfort letters, statutoryaudits, and attest services and consultation regarding financial accounting and/or reporting standards.

2. Audit-Related services are for assurance and related services that are traditionally performed by an independentregistered public accounting firm, including due diligence related to mergers and acquisitions, employee benefit plan audits,and special procedures required to meet certain regulatory requirements.

3. Tax services include all services performed by an independent registered public accounting firm’s tax personnelexcept those services specifically related to the audit of the financial statements, and includes fees in the areas of tax compliance,tax planning, and tax advice.

4. Other Fees are those associated with services not captured in the other categories. The Company generally does notrequest such services from our independent registered public accounting firm.

Priorto engagement, the Audit Committee pre-approves these services by category of service. The fees are budgeted and the Audit Committeerequires our independent registered public accounting firm and management to report actual fees versus the budget periodicallythroughout the year by category of service. During the year, circumstances may arise when it may become necessary to engage ourindependent registered public accounting firm for additional services not contemplated in the original pre-approval. In thoseinstances, the Audit Committee requires specific pre-approval before engaging our independent registered public accounting firm.

TheAudit Committee may delegate pre-approval authority to one or more of its members. The member to whom such authority is delegatedmust report, for informational purposes only, any pre-approval decisions to the Audit Committee at its next scheduled meeting.

PARTIV

ITEM15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES

(a)

c.

Financial Statements

Ourconsolidated financial statements are set forth in Part II, Item 8 of this Annual Report on Form 10-K and are incorporated hereinby reference.

d.

Financial Statement Schedules

Nofinancial statement schedules have been filed as part of this Annual Report on Form 10-K because they are not applicable or arenot required or because the information is otherwise included herein.

e.

Exhibits required by Regulation S-K

No.		Description
2.1		Stock Purchase Agreement, dated February 2, 2020, by and among Orgenesis, Inc., GPP-II Masthercell LLC, Masthercell Global Inc. and Catalent Pharma Solutions, Inc.(incorporated by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on February 3, 2020).
2.2		Agreement and Plan of Merger and Reorganization, dated as of September 26, 2020 by and among Orgenesis Inc., Orgenesis Merger Sub, Inc., Koligo Therapeutics Inc., the Shareholders of Koligo and Long Hill Capital V, LLC, solely in its capacity as representative of the Shareholders (incorporated by reference to an exhibit to our current report on Form 8-K, filed on October 2, 2020)
3.1		Articles of Incorporation, as amended (incorporated by reference to an exhibit to our registration statement on Form S-8, filed on August 7, 2020)
3.2		Amended and Restated Bylaws (incorporated by reference to an exhibit to our current report on Form 8-K, filed on September 21, 2011)
4.1		Description of Securities (incorporated by reference to an exhibit to our annual report on Form 10-K filed on March 9, 2020)
4.2		Form of Warrant (incorporated by reference to an exhibit to our current report on Form 8-K, filed on January 22, 2020)
4.3		Form of Stock Option Agreement (incorporated by reference to an exhibit to our current report on Form S-8, filed on August 7, 2020)
10.1		Convertible Loan Agreement, dated December 6, 2013, with Mediapark A.G. (incorporated by reference to an exhibit to our current report on Form 8-K, filed on December 16, 2013)
10.2		InvestmentAgreement, dated December 13, 2013, with Kodiak Capital Group, LLC (incorporated by reference to an exhibit to our current reporton Form 8-K, filed on December 16, 2013)
10.3		Registration Rights Agreement, dated December 13, 2013, with Kodiak Capital Group, LLC (incorporated by reference to an exhibit to our current report on Form 8-K, filed on December 16, 2013)
10.4		Form of subscription agreement (incorporated by reference to an exhibit to our current report on Form 8-K, filed on March 4, 2014)
10.5		Form of warrant (incorporated by reference to an exhibit to our current report on Form 8-K, filed on March 4, 2014)
10.6		Consulting Agreement, dated April 3, 2014, with Aspen Agency Limited (incorporated by reference to an exhibit to our current report on Form 8-K, filed on April 7, 2014)
10.7		Stock Option Agreement, dated April 3, 2014, with Aspen Agency Limited (incorporated by reference to an exhibit to our current report on Form 8-K, filed on April 7, 2014)
10.8		Form of subscription agreement with form of warrant (incorporated by reference to an exhibit to our current report on Form 8-K, filed on April 28, 2014)
10.9		Convertible Loan Agreement, dated May 29, 2014, with Nine Investments Limited (incorporated by reference to an exhibit to our current report on Form 8-K, filed on May 30, 2014)
10.10		Service Agreement between Orgenesis SPRL and MaSTherCell S.A., dated July 3, 2014 (incorporated by reference to an exhibit to our current report on Form 8-K, filed on July 7, 2014)
10.11		Financial Consulting Agreement, dated August 1, 2014, with Eventus Consulting, P.C. (incorporated by reference to an exhibit to our current report on Form 8-K, filed on August 5, 2014)
10.12		Personal Employment Agreement, dated August 1, 2014, by and between Orgenesis Inc. and Neil Reithinger (incorporated by reference to an exhibit to our current report on Form 8-K, filed on August 5, 2014)
10.13		Executive Employment Agreement, dated March 30, 2017, between Orgenesis Inc. and Vered Caplan (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on July 24, 2017)
10.14		Amendment No. 1, dated May 10, 2017, to Executive Employment Agreement, dated as of March 30, 2017, between Orgenesis Inc. and Vered Caplan (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on July 24, 2017)

No.		Description
10.15		Share Exchange Agreement, dated November 3, 2014, by and between Orgenesis Inc. and MaSTherCell S.A. and Cell Therapy Holding SA (collectively “MaSTherCell”) and each of the shareholders of MaSTherCell (incorporated by reference to an exhibit to our current report on Form 8-K, filed on November 10, 2014)
10.16		Addendum No. 1, dated March 2, 2015, to Share Exchange Agreement, dated November 3, 2014, by and between Orgenesis Inc., MaSTherCell, and each of the shareholders of MaSTherCell (incorporated by reference to an exhibit to our current report on Form 8-K, filed on March 5, 2015)
10.17		Escrow Agreement, dated February 27, 2015, by and between Orgenesis Inc., the shareholders of MaSTherCell S.A. and Cell Therapy Holding SA, the bondholders of MaSTherCell S.A. and Securities Transfer Corporation (incorporated by reference to an exhibit to our current report on Form 8-K, filed on March 5, 2015)
10.18		Orgenesis Inc. Board of Advisors Consulting Agreement, dated March 16, 2015 (incorporated by reference to an exhibit to our current report on Form 8-K, filed on March 17, 2015)
10.19		Addendum No. 2, dated November 12, 2015, to Share Exchange Agreement, dated November 3, 2014, by and between Orgenesis Inc., MaSTherCell, and each of the shareholders of MaSTherCell (incorporated by reference to an exhibit our current report on Form 8-K, filed on November 13, 2015)
10.20		Joint Venture Agreement, dated March 14, 2016, by and between Orgenesis Inc. and CureCell Co., Ltd. (incorporated by reference to an exhibit to our annual report on Form 10-K, filed on February 28, 2017)
10.21		Joint Venture Agreement, dated May 10, 2016, by and between Orgenesis Inc. and Atvio Biotech Ltd. (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on April 19, 2017)
10.22		Private Placement Subscription Agreement, dated January 26, 2017, between Orgenesis Inc. and Image Securities FZC (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on April 19, 2017)
10.23		Amendment No. 1, dated February 9, 2017, to the Private Placement Subscription Agreement, dated January 26, 2017, between Orgenesis Inc. and Image Securities FZC (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on April 19, 2017)
10.24		2017 Equity Incentive Plan (incorporated by reference to an exhibit to our definitive proxy statement on Schedule 14A, filed on March 30, 2017)
10.25		Collaboration and License Agreement, dated as of June 8, 2018, between Orgenesis Inc. and Mircod Limited (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on October 12, 2018)
10.26		Private Placement Subscription Agreement, dated November 13, 2018, between Orgenesis Inc. and Avner Sonnino (incorporated by reference to an exhibit to our current report on Form 8-K, filed on November 20, 2018)
10.27		Private Placement Subscription Agreement, dated November 21, 2018, between Orgenesis Inc. and an accredited investor (incorporated by reference to an exhibit to our current report on Form 8-K, filed on November 28, 2018)
10.28		Private Placement Subscription Agreement, dated November 30, 2018, between Orgenesis Inc. and an accredited investor (incorporated by reference to an exhibit to our current report on Form 8-K, filed on December 6, 2018)
10.29		Private Placement Subscription Agreement, dated December 10, 2018, between Orgenesis Inc. and an accredited investor (incorporated by reference to an exhibit to our current report on Form 8-K, filed on December 14, 2018)
10.30		Controlled Equity Offering Sales Agreement, dated December 20, 2018, between Orgenesis Inc. and Cantor Fitzgerald & Co. (incorporated by reference to an exhibit to our current report on Form 8-K, filed on December 20, 2018)
10.31		Joint Venture Agreement between the Company and First Choice International Company, Inc. dated March 12, 2019 (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on May 8, 2019)

No.		Description
10.32		Convertible Loan Agreement between Orgenesis Maryland Inc. and Yosef Ram dated April 12, 2019 (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on May 8, 2019)
10.33		Joint Venture Agreement between the Company and KinerjaPay Corp. dated May 6, 2019  (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on May 8, 2019)
10.34		Convertible Loan Agreement, dated April 10, 2019, by and between the Company and Investor (incorporated by reference to an exhibit to our quarterly report on form 10-Q, filed on November 7, 2019)
10.35		Form of Subscription Agreement, dated May 17, 2019, by and between the Company and Investor (incorporated by reference to an exhibit to our quarterly report on form 10-Q, filed on November 7, 2019)
10.36		Form of Subscription Agreement, dated May 30, 2019, by and between the Company and Investor (incorporated by reference to an exhibit to our quarterly report on form 10-Q, filed on November 7, 2019)
10.37		Form of Subscription Agreement, dated June 6, 2019, by and between the Company and Investor (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on November 7, 2019)
10.38		Transfer Agreement, dated as of August 7, 2019 by and among Masthercell Global, Orgenesis Inc. and GPP-II Masthercell, LLC (incorporated by reference to our current report on Form 8-K, filed on August 13, 2019)
10.39		2017 Equity Incentive Plan (incorporated by reference to an exhibit to our definitive proxy statement on Schedule 14A, filed on March 30, 2017)
10.40		Securities Purchase Agreement, dated January 20, 2020, by and among the Company and the Investors (incorporated by reference to an exhibit to our current report on Form 8-K, filed on January 22, 2020)
10.41		Registration Rights Agreement, dated January 20, 2020, by and among the Company and the Investors (incorporated by reference to an exhibit to our current report on Form 8-K, filed on January 22, 2020)
10.42		Asset Purchase Agreement by and between Orgenesis Inc. and Tamir Biotechnology, Inc, dated April 12, 2020 (incorporated by reference to an exhibit to our current report on Form 8-K, filed on April 13, 2020)
10.43		Form of Registration Rights and Lock-Up Agreement between the Company, Long Hill Capital V, LLC and Maxim Group, LLC (incorporated by reference to an exhibit to our current report on Form 8-K, filed on October 1, 2020)
10.44		Form of Shareholders Lock-Up Agreement between the Company and Shareholders other than Long Hill Capital V, LLC (incorporated by reference to an exhibit to our current report on Form 8-K, filed on October 1, 2020)
10.45*		Executive Directorship Agreement between the Company and Vered Caplan dated November 19, 2020
10.46*		Swiss Employment Agreement between the Company and Vered Caplan dated November 19, 2020
21.1*		List of Subsidiaries of Orgenesis Inc.
23.1*		Consent of independent registered public accounting firm
31.1*		Certification Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
31.2*		Certification Statement of the Chief Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
32.1**		Certification Statement of the Chief Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
32.2**		Certification Statement of the Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
99.1		Global Share Incentive Plan (2012) (incorporated by reference to an exhibit to our current report on Form 8-K, filed on May 31, 2012)
99.2		Appendix – Israeli Taxpayers Global Share Incentive Plan (2012) (incorporated by reference to an exhibit to our current report on Form 8-K, filed on May 31, 2012)
101.INS*		XBRL Instance Document
101.SCH*		XBRL Taxonomy Extension Schema Document
101.CAL*		XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*		XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*		XBRL Taxonomy Extension Label Linkbase Document
101.PRE*		XBRL Taxonomy Extension Presentation Linkbase Document

*Filedherewith

**Furnishedherewith

ITEM16. FORM 10-K SUMMARY

Notapplicable.

SIGNATURES

Pursuantto the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this reportto be signed on its behalf by the undersigned, thereunto duly authorized.

ORGENESISINC.

By:	/s/ Vered Caplan
Vered Caplan
Chief Executive Officer and Chairperson of the Board of Directors (Principal Executive Officer)
Date:  March 9, 2021

By:	/s/ Neil Reithinger
Neil Reithinger
Chief Financial Officer, Treasurer and Secretary (Principal Financial and Accounting Officer)
Date:  March 9, 2021

Pursuantto the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalfof the registrant and in the capacities and on the dates indicated.

By:	/s/ Vered Caplan
Vered Caplan
Chief Executive Officer and Chairperson of the Board of Directors (Principal Executive Officer)
Date:  March 9, 2021

By:	/s/ Neil Reithinger
Neil Reithinger
Chief Financial Officer, Treasurer and Secretary (Principal Financial and Accounting Officer)
Date:  March 9, 2021

By:	/s/ Guy Yachin
Guy Yachin
Director
Date:  March 9, 2021

By:	/s/ David Sidransky
David Sidransky
Director
Date:  March 9, 2021

By:	/s/ Yaron Adler
Yaron Adler
Director
Date:  March 9, 2021

By:	/ s/ Ashish Nanda
Ashish Nanda
Director
Date:  March 9, 2021

By:	/ s/ Mario Philips
Mario Philips
Director
Date:  March 9, 2021

ITEM8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ORGENESISINC.

CONSOLIDATEDFINANCIAL STATEMENTS AS OF DECEMBER 31, 2020

TABLEOF CONTENTS

	Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM	F-2
CONSOLIDATED FINANCIAL STATEMENTS:
Consolidated Balance Sheets	F-3
Consolidated Statements of Comprehensive Loss (Income)	F-5
Consolidated Statements of Changes in Equity	F-6
Consolidated Statements of Cash Flows	F-8
Notes to Consolidated Financial Statements	F-9 to F-52

REPORTOF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Tothe Board of Directors and shareholders of Orgenesis Inc.:

Opinion on the Financial Statements

We have audited the accompanying consolidatedbalance sheets of Orgenesis Inc. and its subsidiaries (the “Company”) as of December 31, 2020 and 2019, and the relatedconsolidated statements of comprehensive loss (income), changes in equity and cash flows for the years then ended, including therelated notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidatedfinancial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2020 and2019, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generallyaccepted in the United States of America.

Changes in Accounting Principle

As discussed in Note 2(x) to the consolidatedfinancial statements, the Company changed the manner in which it accounts for leases in 2019.

Basis for Opinion

These consolidated financial statementsare the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidatedfinancial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting OversightBoard (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federalsecurities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits of these consolidatedfinancial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the auditto obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whetherdue to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control overfinancial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reportingbut not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.Accordingly, we express no such opinion.

Our audits included performing proceduresto assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts anddisclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significantestimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believethat our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matter communicatedbelow is a matter arising from the current period audit of the consolidated financial statements that was communicated or requiredto be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidatedfinancial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of criticalaudit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not,by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accountsor disclosures to which it relates.

Revenue Recognition - Point-of-Care(“POC”) Cell Therapy Platform

As described in Notes 1 and 2(w) to theconsolidated financial statements, the Company generated approximately $5.9 million in revenue from POC services for the yearended December 31, 2020. The transaction price from those POC services is allocated by management to each distinct performanceobligation based on its relative standalone selling price. The Company recognizes revenue when, or as, it satisfies a performanceobligation. At contract inception, the Company determines whether the services are transferred over time or at a point in time.Revenue related to performance obligations that have no alternative use and that the Company has the right to payment for performancecompleted to date, at all times during the contract term, are recognized over time. Revenue from all other performance obligationsare recognized as revenues by the Company at point of time (upon completion).

The principalconsiderations for our determination that performing procedures relating to revenue recognition - POC cell therapy platform isa critical audit matter are that there was significant judgment by management in (1) identifying the distinct performance obligationsand estimating the standalone selling price of each distinct performance obligation, and (2) identifying which performance obligationscreate assets with alternative use to the Company, which results in revenue recognized upon completion, and which performanceobligations are transferred to the customer over time. This in turn led to significant auditor judgment and effort in performingprocedures to evaluate management’s significant judgment in identifying distinct performance obligations and determiningwhether those performance obligations create assets with alternative use to the Company.

Addressing thematter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidatedfinancial statements. These procedures included testing the effectiveness of controls relating to the revenue recognition process.These procedures also included, among others, on a test basis, testing the completeness and accuracy of management’s identificationof the distinct performance obligations by evaluating customer arrangements; and testing management’s process for determiningthe appropriate amount of revenue recognition based on the performance obligations identified in relevant contracts.

/s/ Kesselman & Kesselman

Certified Public Accountants (Isr.)

A member firm of PricewaterhouseCoopersInternational Limited

Tel-Aviv, Israel

March 9, 2021

We have served as the Company’s auditorsince 2012.

ORGENESISINC.

CONSOLIDATEDBALANCE SHEETS

(U.S.Dollars, in thousands)

		2020				2019
		December 31,
		2020				2019
Assets
CURRENT ASSETS:
Cash and cash equivalents		$	44,923			$	107
Restricted cash			645				467
Accounts receivable, net			3,085				1,831
Prepaid expenses and other receivables			1,070				382
Grants receivable			169				204
Inventory			185				136
Current assets of discontinued operations (See Note 3)			-				75,221
Total current assets			50,077				78,348
NON CURRENT ASSETS:
Deposits		$	296			$	299
Loan to related party			-				2,623
Investments in associates, net			175				-
Property, plants and equipment, net			3,073				2,305
Intangible assets, net			13,023				3,348
Operating lease right-of-use assets			1,474				725
Goodwill			8,745				4,812
Other assets			821				35
Total non-current assets			27,607				14,147
TOTAL ASSETS		$	77,684			$	92,495

ORGENESISINC.

CONSOLIDATEDBALANCE SHEETS

(U.S.Dollars, in thousands)

		December 31,
		2020				2019
Liabilities and equity
CURRENT LIABILITIES:
Accounts payable		$	8,649			$	5,549
Accrued expenses and other payables			792				1,615
Income tax payable			7				-
Employees and related payables			1,463				1,672
Advance payments on account of grant			692				523
Short-term loans and current maturities of long-term loans			145				391
Contract liabilities			59				325
Current maturities of finance leases			19				-
Current maturities of operating leases			485				357
Current maturities of convertible loans			3,974				416
Current liabilities of discontinued operations (See Note 3)			-				31,586
TOTAL CURRENT LIABILITIES			16,285				42,434
LONG-TERM LIABILITIES:
Non-current operating leases		$	1,020			$	455
Convertible loans			7,200				12,143
Retirement benefits obligation			74				41
Deferred taxes			-				58
Long-term debt and finance leases			64				-
Other long-term liabilities			313				331
TOTAL LONG-TERM LIABILITIES			8,671				13,028
TOTAL LIABILITIES			24,956				55,462
COMMITMENTS
REDEEMABLE NON CONTROLLING INTEREST OF DISCONTINUED OPERATIONS (See Note 3)			-				30,955
EQUITY:
Common stock of $ 0.0001 par value, 145,833,334 shares authorized, 24,223,093 and 16,140,962 shares issued as of December 31, 2020 and December 31, 2019, respectively			3				2
Additional paid-in capital			140,397				94,691
Accumulated other comprehensive income			748				213
Treasury stock at December 31, 2020 55,309 shares			( 250	)			-
Accumulated deficit			( 88,319	)			( 89,429	)
Equity attributable to Orgenesis Inc.			52,579				5,477
Non-controlling interests			149				601
TOTAL EQUITY			52,728				6,078
TOTAL LIABILITIES AND EQUITY		$	77,684			$	92,495

Theaccompanying notes are an integral part of these consolidated financial statements.

ORGENESISINC.

CONSOLIDATEDSTATEMENTS OF COMPREHENSIVE LOSS (INCOME)

(U.S.Dollars, in thousands, except share and per share amounts)

		2020				2019
		Year ended December 31,
		2020				2019
Revenues		$	6,177			$	2,629
Revenues from related party			1,475				1,270
Total revenues			7,652				3,899
Cost of research and development and research and development services, net			83,986				14,014
Amortization of intangible assets			478				430
Selling, general and administrative expenses			18,973				11,451
Other income, net			( 4	)			( 21	)
Operating loss			95,781				21,975
Financial expenses, net			1,061				843
Share in net income of associated companies			( 106	)			-
Loss from continuing operation before income taxes			96,736				22,818
Tax income			( 1,609	)			( 229	)
Net loss from continuing operation			95,127				22,589
Net loss (income) from discontinued operations, net of tax			( 95,706	)			3,452
Net loss (income)		$	( 579	)		$	26,041
Net loss attributable to non-controlling interests (including redeemable) from continuing operation			( 39	)			( 99	)
Net loss attributable to non-controlling interests (including redeemable) from discontinued operations			( 492	)			( 1,821	)
Net loss (income) attributable to Orgenesis Inc.		$	( 1,110	)		$	24,121
Loss (income) per share:
Basic and diluted from continuing operations		$	4.46			$	1.41
Basic and diluted from discontinued operations		$	( 4.75	)		$	0.36
Basic and diluted		$	( 0.29	)		$	1.77
Weighted average number of shares used in computation of Basic and Diluted loss per share:
Basic and diluted			21,320,314				15,907,995
Comprehensive loss (income):
Net loss from Continuing Operation		$	95,127			$	22,589
Net loss (income) from Discontinued Operations, Net of Tax			( 95,706	)			3,452
Other Comprehensive (income) loss – Translation adjustment			( 341	)			456
Release of translation adjustment due to sale of subsidiary			( 194	)			-
Comprehensive loss (income)		$	( 1,114	)		$	26,497
Comprehensive loss attributed to non-controlling interests (including redeemable)			( 39	)			( 99	)
Comprehensive loss attributed to non-controlling interests (including redeemable) from discontinued operations			( 492	)			( 1,821	)
Comprehensive loss (income) attributed to Orgenesis Inc.		$	( 1,645	)		$	24,577

Theaccompanying notes are an integral part of these consolidated financial statements.

ORGENESISINC.

CONSOLIDATEDSTATEMENTS OF CHANGES IN EQUITY

(U.S.Dollars, in thousands, except share amounts)

		1				2				3				4				5				6				7				Total
		Common Stock												Accumulated Other								Equity Attributable
		Number				Par Value				Additional Paid-in Capital				Comprehensive Income (loss)				Accumulated Deficit				to Orgenesis Inc.				Non- Controlling Interest				Total
BALANCE AT JANUARY 1, 2019			15,540,333			$	2			$	90,597			$	669			$	( 65,163	)		$	26,105			$	645			$	26,750
Changes during the Year ended December 31, 2019:
Stock-based compensation to employees and directors			-				-				2,106				-								2,106				58				2,164
Stock-based compensation to service providers			75,629				*-				893				-				-				893				-				893
Stock-based compensation for Tamir purchase agreement (See Note 3)			-
Exercise of options			-
Beneficial conversion feature of convertible loans
Issuance of shares and warrants			-
Issuance of shares related to acquisition of Koligo			-
Sale of subsidiaries
Repurchase of treasury stock			-
Stock-based compensation to strategic collaborations			525,000				*-				2,641												2,641				-				2,641
Issuance and modification of warrants and Beneficial conversion feature of convertible loans			-				-				515				-				( 145	)			370				-				370
Transaction with non-controlling interest GPP (See Note 1)			-				-				2,034				-								2,034				-				2,034
Adjustment to redemption value of redeemable non-controlling interest			-				-				( 4,095	)			-				-				( 4,095	)			-				( 4,095	)
Comprehensive loss for the year							-				-				( 456	)			( 24,121	)			( 24,577	)			( 102	)			( 24,679	)
BALANCE AT DECEMBER 31, 2019			16,140,962			$	2			$	94,691			$	213			$	( 89,429	)		$	5,477			$	601			$	6,078

*	Represents an amount lower than $1 thousand

Theaccompanying notes are an integral part of these consolidated financial statement

ORGENESISINC.

CONSOLIDATEDSTATEMENTS OF CHANGES IN EQUITY

(U.S.Dollars, in thousands, except share amounts)

		1				2				3				4				5				6				7				8				Total
		Common Stock												Accumulated Other												Equity Attributable
		Number				Par Value				Additional Paid-in Capital				Comprehensive Income (loss)				Treasury Shares				Accumulated Deficit				to Orgenesis Inc.				Non- Controlling Interest				Par Value
BALANCE AT JANUARY 1, 2020			16,140,962			$	2			$	94,691			$	213			$	-			$	( 89,429	)		$	5,477			$	601			$	6,078
Changes during the Year ended  December 31, 2020:
Stock-based compensation to employees and directors			-				-				1,470				-				-				-				1,470				-				1,470
Stock-based compensation to service providers			** 270,174				1				1,376				-				-				-				1,377				-				1,377
Stock-based compensation for Tamir purchase agreement (See Note 4)			3,400,000				*-				17,748				-				-				-				17,748				-				17,748
Exercise of options			83,334				*-				300				-				-				-				300				-				300
Beneficial conversion feature of convertible loans			-				-				42				-				-				-				42				-				42
Issuance of shares and warrants			2,200,000				-				8,438				-				-				-				8,438				-				8,438
Issuance of shares related to acquisition of Koligo			2,128,623				*-				11,172				-				-				-				11,172				-				11,172
Sale of subsidiaries			-				-				-				-				-				-				-				( 413	)			( 413	)
Adjustment to redemption value of redeemable non-controlling interest			-				-				5,160				-				-				-				5,160				-				5,160
Repurchase of treasury stock			( 55,309	)			-				-				-				( 250	)			-				( 250	)			-				( 250	)
Comprehensive income (loss) for the period			-				-				-				535				-				1,110				1,645				( 39	)			1,606
BALANCE AT DECEMBER 31, 2020			24,167,784			$	3			$	140,397			$	748			$	( 250	)		$	( 88,319	)		$	52,579			$	149			$	52,728

*	Represents an amount lower than $1 thousand
**	out of which 30,000 shares have additional restrictions on transfer until services have been provided.

Theaccompanying notes are an integral part of these consolidated financial statements.

ORGENESISINC.

CONSOLIDATEDSTATEMENTS OF CASH FLOWS(*)

(U.S.Dollars, in thousands)

		2020				2019
		Year ended December 31,
		2020				2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)		$	579			$	( 26,041	)
Adjustments required to reconcile net income (loss) to net cash used in operating activities:
Stock-based compensation			2,847				3,057
Stock-based compensation for strategic collaborations			-				2,641
Stock-based compensation for Tamir Purchase Agreement (See Notes 4)			17,048				-
Capital loss (gain), net			22				( 29	)
Gain on disposal of subsidiaries			( 96,918	)			-
Share in income of associated company			( 106	)			-
Depreciation and amortization expenses			1,435				3,806
Effect of exchange differences on inter-company balances			( 618	)			214
Net changes in operating leases			14				( 339	)
Interest expense accrued on loans and convertible loans (including amortization of beneficial conversion feature)			927				387
Changes in operating assets and liabilities:
Increase in accounts receivable			( 1,350	)			( 5,308	)
Increase in inventory			( 84	)			( 414	)
Increase in other assets			( 24	)			( 46	)
Increase in prepaid expenses, other accounts receivable			( 1,073	)			( 112	)
Increase in accounts payable			1,985				4,626
Increase (decrease) in accrued expenses and other payable			( 1,156	)			271
Increase (decrease) in employee and related payables			( 170	)			474
Increase (decrease) in contract liabilities			( 166	)			3,536
Change in advance payments and receivables on account of grant, net			140				( 247	)
Increase (decrease) in deferred taxes			( 1,378	)			304
Net cash used in operating activities		$	( 78,046	)		$	( 13,220	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Increase in loan to JV partner, a related party			( 500	)			( 1,500	)
Repayment in loan to JV partner, a related party			3,000				-
Sale of property, plants and equipment			7				79
Purchase of property, plants and equipment			( 1,525	)			( 12,129	)
Acquisition of Koligo, net of cash acquired (See Note 4)			( 955	)			-
Proceed from sale of subsidiaries, net			105,634				-
Investment in associated company			( 69	)			-
Repayment (investment) in short term deposits			18				( 228	)
Net cash provided by (used) in investing activities		$	105,610			$	( 13,778	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Repurchase of treasury stock			( 250	)			-
Increase in redeemable non-controlling interests received from GPP			-				13,200
Proceeds from issuance of shares, warrants and exercise of options (net of transaction costs)			8,738				-
Proceeds from issuance of convertible loans (net of transaction costs)			250				11,400
Repayment of convertible loans and convertible bonds			( 2,400	)			-
Repayment of short and long-term debt			( 457	)			( 772	)
Proceeds from issuance of loans payable			-				270
Net cash provided by financing activities		$	5,881			$	24,098
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH			33,445				( 2,900	)
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS		$	82			$	( 58	)
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF YEAR		$	12,041			$	14,999
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF YEAR		$	45,568			$	12,041
SUPPLEMENTAL DISCLOSURE OF CASH FLOW TRANSACTIONS:
Interest paid in cash during the year		$	-			$	157
Income taxes, net of refunds paid in cash during the year		$	-			$	156
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES
Finance Leases of property, plant and equipment		$	366			$	355
Right-of-use assets acquired in exchange for right-of-use liabilities		$	967			$	8,229
Purchase of property, plant and equipment included in accounts payable		$	241			$	1,584
Transaction costs of issuance of convertible loans		$	-			$	546
Acquisition of other asset in exchange for common stocks		$	700			$	-
Issuance of common stocks in connection with the acquisition of Koligo		$	11,172			$	-

(*)	See Note 3 for information regarding the discontinued operations.

Theaccompanying notes are an integral part of these consolidated financial statements.

ORGENESISINC.

NOTESTO CONSOLIDATED FINANCIAL STATEMENTS

NOTE1 – DESCRIPTION OF BUSINESS

a.

General

OrgenesisInc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies in an affordableand accessible format (“CGTs”).

CGTscan be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are partof a class of medicines referred to as advanced therapy medicinal products (ATMP). The Company mostly focusses on autologous therapies,with processes and systems that are developed for each therapy using a closed and automated processing system approach that isvalidated for compliant production near the patient at their point of care for treatment of the patient. This approach has thepotential to overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercialproduction of advanced therapies due to their cost prohibitive nature and complex logistics to deliver the treatments to patients(ultimately limiting the number of patients that can have access to, or can afford, these therapies).

Toachieve these goals, the Company has developed a Point of Care Platform comprised of three enabling components: a pipeline oflicensed POCare Therapies that are designed to be processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network . Via a combination of science, technology, engineering, and networking, theCompany is working to provide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at loweredcosts. The Company also draws on extensive medical expertise to identify promising new autologous therapies to leverage withinthe POCare Platform either via ownership or licensing.

ThePOCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide with a goal ofachieving harmonized, regulated clinical development and production of the therapies.

Overtime, the Company has worked to develop and validate POCare Technologies that can be combined within mobile production units foradvanced therapies. In 2020, the Company made significant investments in the development of several types of Orgenesis MobileProcessing Units and Labs (OMPULs) with the expectation of use and/or distribution through our POCare Network of partners, collaborators,and joint ventures. As of the date of this report, the OMPULs are still in the development stage.

OMPULsare designed for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of potentialor approved cell and gene therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as themanufacturing of such CGTs in a consistent and standardized manner in all locations. The design delivers a potential industrialsolution for the Company to deliver CGTs to practically any clinical institution at the point of care.

UntilDecember 31, 2019, the Company operated the POCare Platform as one of two business separate business segments.

Historically,the second separate business segment was operated as a Contract Development and Manufacturing Organization (“CDMO”)platform, providing contract manufacturing and development services for biopharmaceutical companies (the “CDMO Business”).The CDMO platform was historically operated mainly through majority owned Masthercell Global (which consisted of the followingtwo subsidiaries: MaSTherCell S.A. in Belgium (“MaSTherCell”), and Masthercell U.S., LLC in the United States (“MasthercellU.S.”) (collectively, the “Masthercell Global Subsidiaries”)).

InFebruary 2020, the Company and GPP-II Masthercell LLC (“GPP”) sold 100 % of the outstanding equity interests of Masthercell(the “Masthercell Business”), which comprised the majority of the Company’s CDMO Business, to Catalent PharmaSolutions, Inc. for an aggregate nominal purchase price of $ 315 million, (the “Masthercell Sale”). After accountingfor GPP’s liquidation preference and equity stake in Masthercell as well as other investor interests in our Belgian subsidiaryMaSTherCell, distributions to Masthercell option holders and transaction costs, the company received approximately $ 126.7 million.The Company incurred an additional approximately $ 5.6 million in transaction costs.

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TheCompany determined that the Masthercell Business (“Discontinued Operation”) meets the criteria to be classified asa discontinued operation as of the first quarter of 2020. The Discontinued Operation includes the vast majority of the previousCDMO Business, including majority-owned Masthercell, including MaSTherCell, Masthercell U.S. and all of the Masthercell GlobalSubsidiaries.

Sincethe Masthercell Sale, the Company has entered into new joint venture agreements with new partners in various jurisdictions. Thishas allowed the Company to grow its infrastructure and expand its processing sites into new markets and jurisdictions. In addition,the Company has engaged some of these joint venture partners to perform research and development services to further develop andadapt its systems and devices for specific purposes. The Company has been investing manpower and financial resources to focuson developing, manufacturing and rolling out several types of OMPULs to be used and/or distributed through our POCare Networkof partners, collaborators, and joint ventures.

TheChief Executive Officer (“CEO”) is the Company’s chief operating decision-maker who reviews financialinformation prepared on a consolidated basis. Effective from the first quarter of 2020, all of our continuing operationsare in one segment, being the point-of-care business via our POCare Platform. Therefore, no segment report has beenpresented.

TheCompany currently conducts its core CGT business operations through itself and its subsidiaries which are all wholly-owned exceptas otherwise stated (collectively, the “Subsidiaries”). The Subsidiaries are as follows:

●	United States: Orgenesis Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America currently focused on setting up of the POCare Network.
●	Koligo Therapeutics Inc. (“Koligo”) is a Kentucky corporation that was acquired in 2020 and is currently focused on developing the POCare network and therapies (See Note 4 for the acquisition of Koligo).
●	European Union: Orgenesis Belgium SRL (the “Belgian Subsidiary”) is the center of activity in Europe currently focused on process development and preparation of European clinical trials.
●	Orgenesis Switzerland Sarl (the “Swiss subsidiary) incorporated in October 2020 is currently focused on providing management services to the Company.
●	Israel: Orgenesis Ltd. (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services, and Orgenesis Biotech Israel Ltd. (“OBI”) previously known as Atvio Biotech Ltd. (“Atvio”) is a provider of cell-processing services in Israel.
●	Korea: Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), previously known as CureCell Co. Ltd., is a provider of processing and pre-clinical services in Korea. The Company owns 94.12 % of the Korean Subsidiary.

Theseconsolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries including the Discontinued Operation.

OnApril 7, 2020, the Company entered into an Asset Purchase Agreement (the “Tamir Purchase Agreement”) with Tamir Biotechnology,Inc. (“Tamir” or “Seller”), pursuant to which the Company agreed to acquire certain assets and liabilitiesof Tamir related to the discovery, development and testing of therapeutic products for the treatment of diseases and conditionsin humans, including all rights to Ranpirnase and use for antiviral therapy (collectively, the “Purchased Assets and AssumedLiabilities” and such acquisition, the “Tamir Transaction”). The Tamir Transaction closed on April 23, 2020.As aggregate consideration for the acquisition, the Company paid $ 2.5 million in cash and issued an aggregate of 3,400,000 shares(the “Shares”) of Common Stock to Tamir resulting in a total consideration of $ 20.2 million (See Note 4).

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TheCompany’s common stock, par value $ 0.0001 per share (the “Common Stock”) is listed and traded on the NasdaqCapital Market under the symbol “ORGS.”

Asused in this report and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its Subsidiaries.Unless otherwise specified, all amounts are expressed in United States Dollars.

b.

Liquidity

Asof December 31, 2020 ,the Company has accumulated losses of approximately $ 88 Million.

OnFebruary 10, 2020, the Company received approximately $ 126.7 million, of which $ 7.2 million was used for the repayment ofintercompany loans and payables, from the Masthercell Sale (See Note 3). In addition, on January 20, 2020, the Companyentered into a Securities Purchase Agreement with certain investors pursuant to which the Company received gross proceeds of approximately$ 9.24 million before deducting related offeringexpenses.

TheCompany invested significant resources in research and development and research and development services in 2020. The Companybelieves that these investments will enable it to substantially increase revenues in the next 12 months. Based on its currentcash resources and commitments, the Company believes it will be able to maintain its current planned development activities andexpected level of expenditures for at least 12 months from the date of the issuance of these financial statements. If there arefurther increases in operating costs for facilities expansion, research and development, commercial and clinical activity or decreasesin revenues from customers, the Company may decide to seek additional financing.

NOTE2 - SIGNIFICANT ACCOUNTING POLICIES

The consolidated financialstatements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”).

a. Use of Estimates in the Preparation of Financial Statements

Thepreparation of our consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgmentsand assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosureof contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, judgments and methodologies. We base ourestimates on historical experience and on various other assumptions that we believe are reasonable, the results of which formthe basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expensesand determining whether an acquisition is a business combination or a purchase of asset. Actual results could differ from thoseestimates.

Thefull extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financialcondition, will depend on future developments that are uncertain, including as a result of new information that may emerge concerningCOVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national andinternational customers and markets. We examined the impact of COVID-19 on our financial statements, and although there is currentlyno major impact, there may be changes to those estimates in future periods. Actual results may differ from these estimates.

b. Business Combination

TheCompany allocates the purchase price of an acquired business to the tangible and intangible assets acquired and liabilities assumedbased upon their estimated fair values on the acquisition date. Any excess of the purchase price over the fair value of the netassets acquired is recorded as goodwill. Acquired in-process backlog, customer relations, technology, IPR&D, brand name andknow how are recognized at fair value. The purchase price allocation process requires management to make significant estimatesand assumptions, especially at the acquisition date with respect to intangible assets. Direct transaction costs associated withthe business combination are expensed as incurred. The allocation of the consideration transferred in certain cases may be subjectto revision based on the final determination of fair values during the measurement period, which may be up to one year from theacquisition date. The Company includes the results of operations of the business that it has acquired in its consolidated resultsprospectively from the date of acquisition.

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Ifthe business combination is achieved in stages, the acquisition date carrying value of the acquirer’s previously held equityinterest in the acquire is re-measured to fair value at the acquisition date; any gains or losses arising from such re-measurementare recognized in profit or loss.

c. Other Investments

Forother investments, the Company applies the measurement alternative upon the adoption of ASU 2016-01, and elected to record equityinvestments without readily determinable fair values at cost, less impairment, adjusted for subsequent observable price changes.In this measurement alternative method, changes in the carrying value of the equity investments are reflected in current earnings.Changes in the carrying value of the equity investment are required to be made whenever there are observable price changes inorderly transactions for the identical or similar investment of the same issuer.

d. Discontinued operations

Upondivestiture of a business, the Company classifies such business as a discontinued operation, if the divested business representsa strategic shift that has (or will have) a major effect on an entity’s operations and financial results. For disposalsother than by sale such as abandonment, the results of operations of a business would not be recorded as a discontinued operationuntil the period in which the business is actually abandoned.

TheMasthercell Business divestiture qualifies as a discontinued operation and therefore has been presented as such.

Theresults of businesses that have qualified as a discontinued operation have been presented as such for all reporting periods. Resultsof discontinued operations include all revenues and expenses directly derived from such businesses; general corporate overheadis not allocated to discontinued operations. Any loss or gain that arose from the divestiture of a business that qualifies asdiscontinued operations is included within the results of the discontinued operations. The Company included information regardingcash flows from discontinued operations (See Note 3).

e. Cash Equivalents

TheCompany considers cash equivalents to be all short-term, highly liquid investments, which include money market instruments, thatare not restricted as to withdrawal or use, and short-term bank deposits with original maturities of three months or less fromthe date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash.

f. Cost of research and development and research and development services, net

Costof research and development and research and development services include costs directly attributable to the conduct of researchand development activities, including the cost of salaries, stock-based compensation expenses, payroll taxes and other employees’benefits, lab expenses, consumable equipment, courier fees, travel expenses, professional fees and consulting fees. All costsassociated with research and developments are expensed as incurred. Participation from government departments and from researchfoundations for development of approved projects is recognized as a reduction of expense as the related costs are incurred. Researchand development in-process acquired as part of an asset purchase, which has not reached technological feasibility and has no alternativefuture use, is expensed as incurred.

g. Principles of Consolidation

Theconsolidated financial statements include the accounts of the Company and its Subsidiaries. All intercompany transactions andbalances have been eliminated in consolidation.

F- 12

h. Non-Marketable Equity Investments

TheCompany’s investments in certain non-marketable equity securities in which it has the ability to exercise significant influence,but it does not control through variable interests or voting interests. These are accounted for under the equity method of accountingand presented as Investment in associates, net, in the Company’s consolidated balance sheets. Under the equity method, theCompany recognizes its proportionate share of the comprehensive income or loss of the investee. The Company’s share of incomeand losses from equity method investments is included in share in losses of associated company.

TheCompany reviews its investments accounted for under the equity method for possible impairment, which generally involves an analysisof the facts and changes in circumstances influencing the investments.

i. Functional Currency

Thecurrency of the primary economic environment in which the operations of the Company and part of its Subsidiaries are conductedis the U.S. dollar (“$” or “dollar”). The functional currency of the Belgian Subsidiaries is the Euro(“€” or “Euro”). The functional currency of Orgenesis Korea is the Won (“KRW”). Mostof the Company’s expenses are incurred in dollars, and the source of the Company’s financing has been provided indollars. Thus, the functional currency of the Company and its other subsidiaries is the dollar. Transactions and balances originallydenominated in dollars are presented at their original amounts. Balances in foreign currencies are translated into dollars usinghistorical and current exchange rates for nonmonetary and monetary balances, respectively. For foreign transactions and otheritems reflected in the statements of operations, the following exchange rates are used: (1) for transactions – exchangerates at transaction dates or average rates and (2) for other items (derived from nonmonetary balance sheet items such as depreciation)– historical exchange rates. The resulting transaction gains or losses are recorded as financial income or expenses. Thefinancial statements of the Belgian Subsidiaries and Orgenesis Korea are included in the consolidated financial statements, translatedinto U.S. dollars. Assets and liabilities are translated at year-end exchange rates, while revenues and expenses are translatedat yearly average exchange rates during the year. Differences resulting from translation of assets and liabilities are presentedas other comprehensive income.

j. Inventory

TheCompany’s inventory consists of raw material for use for the services provided. The Company periodically evaluates the quantitieson hand. Cost of the raw materials is determined using the weighted average cost method. The inventory is recorded at the lowerof cost or net realizable value.

k. Property, plant and Equipment

Property,plant and equipment are recorded at cost and depreciated by the straight-line method over the estimated useful lives of the relatedassets.

Annualrates of depreciation are presented in the table below:

SCHEDULE OF ANNUAL DEPRECIATION RATES, PROPERTY AND EQUIPMENT

		Weighted Average Useful Life (Years)
Production facility		5 - 10
Laboratory equipment		2 - 7
Office equipment and computers		3 - 17

l. Intangible assets

Intangibleassets and their useful lives are as follows:

SCHEDULE OF INTANGIBLE ASSETS AND THEIR USEFUL LIVE

		Useful Life (Years)		Amortization Recorded at Comprehensive Loss Line Item
Customer Relationships		10		Amortization of intangible assets
Know-How		12		Amortization of intangible assets
Technology		15		Amortization of intangible assets

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Intangibleassets are recorded at acquisition less accumulated amortization and impairment. Definite lived intangible assets are amortizedover their estimated useful life using the straight-line method, which is determined by identifying the period over which thecash flows from the asset are expected to be generated.

m. Goodwill

Goodwill representsthe excess of consideration transferred over the value assigned to the net tangible and identifiable intangible assets of businessesacquired. Goodwill is allocated to reporting units expected to benefit from the business combination. Goodwill is not amortizedbut rather tested for impairment at least annually in the fourth quarter, or more frequently if eventsor changes in circumstances indicate that goodwill may be impaired. Following the sale of Masthercell the Company managesthe business as one operating segment and one reporting unit. Goodwill impairment is recognized when the quantitative assessmentresults in the carrying value exceeding the fair value, in which case an impairment charge is recorded to the extent thecarrying value exceeds the fair value.

Therewere no impairmentcharges to goodwill during the periods presented.

n. Impairment of Long-lived Assets

TheCompany reviews its property, plants and equipment, intangible assets subject to amortization and other long-lived assets forimpairment whenever events or changes in circumstances indicate that the carrying amount of an asset class may not be recoverable.Indicators of potential impairment include: an adverse change in legal factors or in the business climate that could affect thevalue of the asset; an adverse change in the extent or manner in which the asset is used or is expected to be used, or in itsphysical condition; and current or forecasted operating or cash flow losses that demonstrate continuing losses associated withthe use of the asset. If indicators of impairment are present, the asset is tested for recoverability by comparing the carryingvalue of the asset to the related estimated undiscounted future cash flows expected to be derived from the asset. If the expectedcash flows are less than the carrying value of the asset, then the asset is considered to be impaired and its carrying value iswritten down to fair value, based on the related estimated discounted cash flows. There were no impairment charges in the yearended December 31, 2020 and 2019.

o. Income Taxes

1)With respect to deferred taxes, income taxes are computed using the asset and liability method. Under the asset and liabilitymethod, deferred income tax assets and liabilities are determined based on the differences between the financial reporting andtax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance isrecognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future.

2)The Company follows a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate thetax position for recognition by determining if the available evidence indicates that it is more likely than not that the positionwill be sustained on examination. If this threshold is met, the second step is to measure the tax position as the largest amountthat is greater than 50 % likely of being realized upon ultimate settlement.

3)Taxes that would apply in the event of disposal of investment in Subsidiaries have not been taken into account in computing thedeferred income taxes, as it is the Company’s intention to hold these investments and not realize them.

F- 14

p. Stock-based Compensation

The Company recognizesstock-based compensation for the estimated fair value of share-based awards. The Company measures compensation expense for share-basedawards based on estimated fair values on the date of grant using the Black-Scholes option-pricing model. This option pricing modelrequires estimates as to the option’s expected term and the price volatility of the underlying stock. The Company amortizesthe value of share-based awards to expense over the vesting period on a straight-line basis.

q. Redeemable Non-controlling Interest

Non-controllinginterests with embedded redemption features, whose settlement is not at the Company’s discretion, are considered redeemablenon-controlling interest. Redeemable non-controlling interests are considered to be temporary equity and are therefore presentedas a mezzanine section between liabilities and equity on the Company’s consolidated balance sheets. Subsequent adjustmentof the amount presented in temporary equity is required only if the Company’s management estimates that it is probable thatthe instrument will become redeemable. Adjustments of redeemable non-controlling interest to its redemption value are recordedthrough additional paid-in capital.

r. Loss (income) per Share of Common Stock

Basicnet loss (income) per share is computed by dividing the net loss (income) for the period by the weighted averagenumber of shares of common stock outstanding for each period. Diluted net loss (income) per share is based upon the weightedaverage number of common shares and of common shares equivalents outstanding when dilutive. Common share equivalents include:(i) outstanding stock options and warrants which are included under the treasury share method when dilutive, and (ii) common sharesto be issued under the assumed conversion of the Company’s outstanding convertible loans and debt, which are included underthe if-converted method when dilutive (See Note 14).

s. Concentration of Credit Risk

Financialinstruments that potentially subject the Company to concentration of credit risk consist of principally cash and cash equivalents,bank deposits and certain receivables. The Company held these instruments with highly rated financial institutions and the Companyhas not experienced any significant credit losses in these accounts and does not believe the Company is exposed to any significantcredit risk on these instruments apart of accounts receivable. The Company performs ongoing credit evaluations of its customersfor the purpose of determining the appropriate allowance for doubtful accounts. An appropriate allowance for doubtful accountsis included in the accounts and netted against accounts receivable. In the year ended December 31, 2020 the Company has not experiencedany material credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments.

Baddebt allowance is created when objective evidence exists of inability to collect all sums owed it under the original terms ofthe debit balances. Material customer difficulties, the probability of their going bankrupt or undergoing economic reorganizationand insolvency or material delays in payments are all considered indicative of reduced debtor balance value.

t. Treasury shares

TheCompany repurchases its ordinary shares from time to time on the open market and holds such shares as treasury stock. The Companypresents the cost to repurchase treasury stock as a reduction of shareholders’ equity. During the years ended December 31,2020, the Company repurchased 55,309 shares. The Company did not reissue nor cancel treasuryshares during the year ended December 31, 2020.

u. Beneficial Conversion Feature (“BCF”)

Whenthe Company issues convertible debt, if the stock price is greater than the effective conversion price (after allocation of thetotal proceeds) on the measurement date, the conversion feature is considered “beneficial” to the holder. If thereis no contingency, this difference is treated as issued equity and reduces the carrying value of the host debt; the discount isaccreted as deemed interest on the debt (See Note 7).

F- 15

v. Other Comprehensive Loss

Othercomprehensive loss represents adjustments of foreign currency translation.

w. Revenue from Contracts with Customers

TheCompany recognizes revenue from contracts with customers according to ASC 606, Revenue from Contracts with Customers andthe related amendments (“New Revenue Standard”) to all contracts.

TheCompany’s agreements are primarily service contracts that range in duration from a few months to one year. The Company recognizesrevenue when control of these services is transferred to the customer for an amount, referred to as the transaction price, whichreflects the consideration to which the Company is expected to be entitled in exchange for those goods or services.

Acontract with a customer exists only when:

●	the parties to the contract have approved it and are committed to perform their respective obligations;
●	the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”);
●	the Company can determine the transaction price for the goods or services to be transferred; and
●	the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer.

TheCompany does not adjust the promised amount of consideration for the effects of a significant financing component since the Companyexpects, at contract inception, that the period between the time of transfer of the promised goods or services to the customerand the time the customer pays for these goods or services to be generally one year or less. The Company’s credit termsto customers are in average between thirty and one hundred and fifty days.

Natureof Revenue Streams

TheCompany’s main revenue streams from continuing operation are POC development services and Cell Process DevelopmentServices.

POCDevelopment Services

Revenuerecognized under contracts for POC development services may, in some contracts, represent multiple performance obligations (wherepromises to the customers are distinct) in circumstances in which the work packages are not interrelated or the customer is ableto complete the services performed.

Forarrangements that include multiple performance obligations, the transaction price is allocated to the identified performance obligationsbased on their relative standalone selling prices.

TheCompany recognizes revenue when, or as, it satisfies a performance obligation. At contract inception, the Company determines whetherthe services are transferred over time or at a point in time. Performance obligations that have no alternative use and that theCompany has the right to payment for performance completed to date, at all times during the contract term, are recognized overtime. All other Performance obligations are recognized as revenues by the company at point of time (upon completion).

Includedin POC development services is Hospital supplies revenue which is derived principally from the sale or lease of products and theperformance of services to hospitals or other medical providers. Revenue is earned and recognized when product and services arereceived by the customer.

SignificantJudgement and Estimates

Significantjudgment is required to identifying the distinct performance obligations and estimating the standalone selling price ofeach distinct performance obligation, and identifying which performance obligations create assets with alternative use to theCompany, which results in revenue recognized upon completion, and which performance obligations are transferred to the customerover time.

PracticalExpedients

Aspart of ASC 606, the Company has adopted several practical expedients including the Company’s determination that it neednot adjust the promised amount of consideration for the effects of a significant financing component since the Company expects,at contract inception, that the period between when the Company transfers a promised service to the customer and when the customerpays for that service will be one year or less.

F- 16

CellProcess Development Services (mainly discontinued operations)

Revenuerecognized under contracts for cell process development services may, in some contracts, represent multiple performance obligations(where promises to the customers are distinct) in circumstances in which the work packages and milestones are not interrelatedor the customer is able to complete the services performed independently or by using competitors of the Company. In other contractswhen the above circumstances are not met, the promises are not considered distinct and the contract represents one performanceobligation. All performance obligations are satisfied over time, as there is no alternative use to the services it performs, since,in nature, those services are unique to the customer, which retain the ownership of the intellectual property created throughthe process. Additionally, due to the non-refundable upfront payment the customer pays, together with the payment term and cancellationfine, it has a right to payment (which include a reasonable margin), at all times, for work completed to date, which is enforceableby law.

Forarrangements that include multiple performance obligations, the transaction price is allocated to the identified performance obligationsbased on their relative standalone selling prices. For these contracts, the standalone selling prices are based on the Company’snormal pricing practices when sold separately with consideration of market conditions and other factors, including customer demographicsand geographic location.

TheCompany measures the revenue to be recognized over time on a contract by contract basis, determining the use of either a cost-basedinput method or output method, depending on whichever best depicts the transfer of control over the life of the performance obligation.

TechTransfer Services (discontinued operations)

Revenuerecognized under contracts for tech transfer services are considered a single performance obligation, as all work packages (includingdata collection, GMP documentation, validation runs) and milestones are interrelated. Additionally, the customer is unable tocomplete services of work performed independently or by using competitors of the Company. Revenue is recognized over time usinga cost-based based input method where progress on the performance obligation is measured by the proportion of actual costs incurredto the total costs expected to complete the contract.

CellManufacturing Services (discontinued operations)

Revenuesfrom cell manufacturing services represent a single performance obligation which is recognized over time. The progress towardscompletion will continue to be measured on an output measure based on direct measurement of the value transferred to the customer(units produced).

ReimbursedExpenses (discontinued operations)

TheCompany includes reimbursed expenses in revenues and costs of revenue as the Company is primarily responsible for fulfilling thepromise to provide the specified service, including the integration of the related services into a combined output to the customer,which are inseparable from the integrated service. These costs include such items as consumable, reagents, transportation andtravel expenses, over which the Company has discretion in establishing prices.

F- 17

ChangeOrders

Changesin the scope of work are common and can result in a change in transaction price, equipment used and payment terms. Change ordersare evaluated on a contract-by-contract basis to determine if they should be accounted for as a new contract or as part of theexisting contract. Generally, services from change orders are not distinct from the original performance obligation. As a result,the effect that the contract modification has on the contract revenue, and measure of progress, is recognized as an adjustmentto revenue when they occur.

Costsof Revenue (discontinued operations)

Costsof revenue include (i) compensation and benefits for billable employees and personnel involved in production, data managementand delivery, and the costs of acquiring and processing data for the Company’s information offerings; (ii) costs of staffdirectly involved with delivering services offerings and engagements; (iii) consumables used for the services; and (iv) otherexpenses directly related to service contracts such as courier fees, laboratory supplies, professional services and travel expenses.

x. Leases

The Company adoptedthe new lease standard ASC 842 and all the related amendments on January 1, 2019.

TheCompany determines if an arrangement is a lease at inception. Lease classification is governed by five criteria in ASC 842-10-25-2.If any of these five criteria is met, The Company classifies the lease as a finance lease; otherwise, the Company classifies thelease as an operating lease. When determining lease classification, the Company’s approach in assessing two of the mentionedcriteria is: (i) generally 75% or more of the remaining economic life of the underlying asset is a major part of the remainingeconomic life of that underlying asset; and (ii) generally 90% or more of the fair value of the underlying asset comprises substantiallyall of the fair value of the underlying asset.

Operatingleases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the consolidatedbalance sheet.

ROUassets represent Orgenesis’s right to use an underlying asset for the lease term and lease liabilities represent its obligationto make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement datebased on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on theinformation available at the commencement date to determine the present value of the lease payments.

Thestandard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term leaserecognition exemption for all leases with a term shorter than 12 months. This means that for those leases, the Company does notrecognize ROU assets or lease liabilities, including not recognizing ROU assets or lease liabilities for existing short-term leasesof those assets in transition, but recognizes lease expenses over the lease term on a straight-line basis.

Leaseterms will include options to extend or terminate the lease when it is reasonably certain that Orgenesis will exercise or notexercise the option to renew or terminate the lease.

y. Recently issued accounting pronouncements, not yet adopted

InJune 2016, the FASB issued ASU 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses onFinancial Instruments.” This guidance replaces the current incurred loss impairment methodology with a methodology thatreflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to informcredit loss estimates. The guidance will be effective for Smaller Reporting Companies (SRCs, as defined by the SEC) for the fiscalyear beginning on January 1, 2023, including interim periods within that year. The Company is currently evaluating this guidanceto determine the impact it may have on its consolidated financial statements.

F- 18

InAugust 2020, the FASB issued Accounting Standards Update (“ASU”) 2020-06, Debt with Conversion and Other Options (Subtopic470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)-Accounting For Convertible Instrumentsand Contracts in an Entity’s Own Equity. The ASU simplifies accounting for convertible instruments by removing major separationmodels required under current GAAP. Consequently, more convertible debt instruments will be reported as a single liability instrumentwith no separate accounting for embedded conversion features. The ASU removes certain settlement conditions that are requiredfor equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify for it.The ASU also simplifies the diluted net income per share calculation in certain areas. The new guidance is effective for annualand interim periods beginning after December 15, 2021, and early adoption is permitted for fiscal years beginning after December15, 2020, and interim periods within those fiscal years. The Company is currently evaluating the impact that this new guidancewill have on its consolidated financial statements.

z. Newly issued and recently adopted accounting pronouncements

TheCompany early adopted ASU 2019-12 on January 1, 2020, which did not have a material impact on the Consolidated Financial Statementsexcept for the removal of the exception related to intra-period tax allocations. Commencing from January 1, 2020, the Companyfollowed the general intra-period allocation of tax expenses. The Company had incurred a loss from continuing operations and subsequentto the adoption of ASU 2019-12, the Company determined the amount attributable to continuing operations without regard to thetax effect of other items. The ASU 2019-12 amendment related to the intra-period tax allocation was applied prospectively.

Hadthe Company not adopted ASU 2019-12, an approximately $ 20 million tax benefit would have been recognized along with correspondingdecreases to net loss from continuing operations with a corresponding increase in tax expenses and decrease in net income resultingfrom discontinued operations. The Company had no intra-period tax allocation items in prior years.

aa. Reclassifications

Certainreclassifications have been made to the prior years’ financial statements to conform to the current year presentation. Thesereclassifications had no net effect on previously reported results of operations.

NOTE3 – DISCONTINUED OPERATION

OnFebruary 2, 2020, the Company entered into a Purchase Agreement with GPP, Masthercell and the Buyer. Pursuant to the terms andconditions of the Purchase Agreement, Sellers agreed to sell 100 % of the outstanding equity interests of Masthercell to Buyerfor an aggregate nominal purchase price of $ 315 million. The Company has determined that the Masthercell Business meets the criteriato be classified as discontinued operations.

OnFebruary 10, 2020, the Masthercell Sale was consummated in accordance with the terms of the Purchase Agreement. After accountingfor GPP’s liquidation preference and equity stake in Masthercell, as well as SFPI – FPIM’s interest in MaSTherCell,distributions to Masthercell option holders and transaction costs, the Company received approximately $ 126.7 million at the closingof the Masthercell Sale, of which $ 7.2 million was used for the repayment of intercompany loans and payables, including $ 4.6 millionof payables to MaSTherCell.

Dueto the sale of the controlling interest in Masthercell, the Company retrospectively reclassified the assets and liabilities ofthese entities as assets and liabilities of discontinued operations and included the financial results of these entities as discontinuedoperations in the Company’s consolidated financial statements.

Discontinuedoperations relate to the Masthercell Business. The comprehensive loss and balance sheet for this operation are separately reportedas discontinued operations for all periods presented.

F- 19

Thefinancial results of the Masthercell Business are presented as income (loss) from discontinued operations, net of income taxeson the Company’s consolidated statement of comprehensive loss. The following table presents the financial results associatedwith the Masthercell Business operation as reflected in the Company’s Consolidated Comprehensive loss (in thousands):

SCHEDULE OF DISCONTINUED OPERATION AND BALANCE SHEETS

		Year Ended December 31,
		2020				2019
OPERATIONS
Revenues		$	2,556			$	31,053
Cost of revenues			1,482				18,318
Cost of research and development and research and development services, net			7				54
Amortization of intangible assets			137				1,631
Selling, general and administrative expenses			1,896				13,886
Other (income) expenses, net			305				( 207	)
Operating loss			1,271				2,629
Financial expenses (income), net			( 29	)			31
Loss before income taxes			1,242				2,660
Tax expenses (income)			( 30	)			792
Net loss from discontinuing operation, net of tax		$	1,212			$	3,452
DISPOSAL
Gain on disposal before income taxes		$	96,918			$	-
Provision for income taxes			-				-
Gain on disposal		$	96,918			$	-
Net profit (loss) from discontinuing operation, net of tax		$	95,706			$	( 3,452	)

Thefollowing table is a summary of the assets and liabilities of discontinued operations (in thousands):

		December 31, 2019
Assets
CURRENT ASSETS:
Cash and cash equivalents		$	11,281
Restricted cash			186
Accounts receivable, net			6,654
Prepaid expenses and other receivables			845
Grants receivable			1,979
Inventory			1,907
Deposits			326
Property and equipment, net			22,149
Intangible assets, net (mainly Know How)			10,858
Operating lease right-of-use assets			8,860
Goodwill			10,129
Other assets			47
TOTAL CURRENT ASSETS OF DISCONTINUED OPERATIONS		$	75,221

		December 31, 2019
CURRENT LIABILITIES:
Accounts payable		$	5,756
Accrued expenses and other payables			372
Employees and related payables			2,047
Advance payments on account of grant			2,227
Short-term loans and current maturities of long- term loans			372
Contract liabilities			8,301
Current maturities of long-term finance leases			291
Current maturities of operating leases			1,365
Non-current operating leases			7,069
Loans payable			1,230
Deferred taxes			1,868
Long-term finance leases			688
TOTAL CURRENT LIABILITIES OF DISCONTINUED OPERATIONS		$	31,586

F- 20

Property,plants and equipment, net and right-of-use assets by geographical location were as follows:

		December 31, 2019
United States		$	16,707
Belgium			14,302
Total		$	31,009

Thefollowing table represents the components of the cash flows from discontinued operations (in thousands):

		Year Ended December 31,
		2020				2019
Net cash flows used in operating activities		$	( 2,409	)		$	( 1,248	)
Net cash flows used in investing activities		$	( 579	)		$	( 11,621	)
Net cash flows (used in) provided by financing activities		$	( 51	)		$	12,570

Disaggregationof Revenue

Thefollowing table disaggregates the Company’s revenues by major revenue streams related to discontinued operations (in thousands):

SCHEDULE OF DISAGGREGATION OF REVENUE RELATED TO DISCONTINUED OPERATIONS

		Year Ended December 31,
		2020				2019
Revenue stream:
Cell process development services		$	2,556			$	20,834
Tech transfer services			-				5,396
Cell manufacturing services			-				4,823
Total		$	2,556			$	31,053

RedeemableNon-Controlling Interest of Discontinued Operations

a.	Subscription and Shareholders Agreement with Belgian Sovereign Funds Société Fédérale de Participations et d’Investissement (“SFPI”).

OnNovember 15, 2017, the Company, MaSTherCell and SFPI entered into a Subscription and Shareholders Agreement (“SFPI Agreement”)pursuant to which SFPI made an equity investment in MaSTherCell.

Dueto the embedded redemption feature of the SPFI agreement whose settlement was not at the Company discretion, the Company had accountedfor the investment made by GPP as a redeemable non-controlling interest.

F- 21

b.	Stock Purchase Agreement and Stockholders’ Agreement with Great Point Partners, LLC (“GPP”)

OnJune 28, 2018, the Company, Masthercell Global GPP, and certain of GPP’s affiliates, entered into a series ofdefinitive strategic agreements intended to finance, strengthen and expand Orgenesis’ CDMO business. Due to theembedded redemption feature of the GPP agreement whose settlement was not at the Company discretion, the Company hadaccounted for the investment made by GPP as a redeemable non-controlling interest.

NOTE4 – ACQUISITION AND REORGANIZATION

TamirBiotechnology, Inc.

OnApril 7, 2020, the Company entered into the Tamir Purchase Agreement with Tamir, pursuant to which the Company agreed to acquirecertain assets and liabilities of Tamir related to the discovery, development and testing of therapeutic products for the treatmentof diseases and conditions in humans, including all rights to Ranpirnase and use for antiviral therapy. The Tamir Transactionclosed on April 23, 2020.

Asaggregate consideration for the acquisition, the Company paid $ 2.5 million in cash and issued an aggregate of 3,400,000 shares(the “Shares”) of Common Stock to Tamir resulting in a total consideration of $ 20.2 million based on the Company’sshare price at the closing date. $ 59 thousand and 340,000 Shares are being held in an escrow account for a period of 18 monthsfrom closing to secure indemnification obligations of Tamir pursuant to the terms of the Tamir Purchase Agreement. $ 4.5 millionof the consideration was attributable to research and development related inventory and most of the remaining amount reflectedthe cost of intangible assets. The Shares were registered for resale by the Company in November 2020.

TheCompany’s acquired right to Tamir’s intellectual property represents a single identifiable asset sourced from theagreement. Because substantially all (more than 90%) of the fair value of the gross assets acquired are concentrated in a singleasset being the right to Tamir’s intellectual property and related assets (“IPR&D”), the Company determinedthat the acquisition is not considered a business in accordance with ASC 805-10-55-5A. Therefore, the Company accounted the transactionas an asset acquisition. The fair value associated with Tamir’s IPR&D in the amount of $ 19.5 million was charged toresearch and development expenses under ASC 730. The remaining amount was attributed to the above-mentioned share in a privatecompany, which is presented in the balance sheet as long term “other assets.

Descriptionof Koligo Acquisition during 2020

OnSeptember 26, 2020, the Company entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”)by and among the Company, Orgenesis Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“MergerSub”), Koligo Therapeutics Inc., a Kentucky corporation (“Koligo”), the shareholders of Koligo (collectively,the “Shareholders”), and Long Hill Capital V, LLC (“Long Hill”), solely in its capacity as the representative,agent and attorney-in-fact of the Shareholders. The Merger Agreement provides for the acquisition of Koligo by the Company throughthe merger of Merger Sub with and into Koligo, with Koligo surviving as a wholly-owned subsidiary of the Company (the “Merger”).The acquisition was completed on October 15, 2020 (the “Effective Time”).

Koligois a privately-held US regenerative medicine company. Koligo’s first commercial product is KYSLECEL® (autologous pancreaticislets) for chronic and acute recurrent pancreatitis. Koligo’s 3D-V technology platform incorporates the use of advanced3D bioprinting techniques and vascular endothelial cells to support development of transformational cell and tissue products forserious diseases.

Pursuantto the terms of the Merger Agreement, at the Effective Time, the shares of capital stock of Koligo that were issued and outstandingimmediately prior to the Effective Time were automatically cancelled and converted into the right to receive, subject to customaryadjustments, an aggregate of 2,061,713 shares of Company common stock whichhave been issued to Koligo’s accredited investors (with certain non-accredited investors being paid solely in cash inthe amount of approximately $ 20 thousand). In addition, we issued 66,910 shares to Maxim Group LLC for advisory services in connectionwith the Merger. The share price was $ 5.26 at the day of the closing.

F- 22

TheMerger Agreement contains customary indemnification provisions whereby the Shareholders of Koligo will indemnify the Company andcertain affiliated parties for any losses arising out of breaches of the representations, warranties and covenants of Koligo andthe Shareholders under the Merger Agreement. As partial security for the indemnification and purchase price adjustment obligationsof Koligo shareholders under the Merger Agreement, $ 7 thousand in cash and 328,587 shares of Company common stock of the mergerconsideration otherwise payable in the Merger to the Shareholders were placed in a third party escrow account. The aggregate indemnificationobligations of the Koligo shareholders under the Merger Agreement is capped at the amounts in escrow, subject to certain limitedexceptions.

Inaddition, according to the agreement between the parties, the Company has also funded an additional cash consideration of $ 500 thousand (with $ 100 thousand of such reducing the ultimate consideration payable to Koligo) for the acquisition of the assetsof Tissue Genesis, LLC (“Tissue Genesis”) by Koligo that was consummated on October 14, 2020. The Tissue Genesis assetsinclude the entire inventory of Tissue Genesis Icellator® devices, related kits and reagents, a broad patent portfolio toprotect the technology, registered trademarks, clinical data, and existing business relationships for commercial and developmentstage use of the Icellator technology.

Inconnection with the Merger Agreement, the Company, Long Hill and Maxim Group LLC (“Maxim”) entered into a RegistrationRights and Lock-Up Agreement pursuant to which Long Hill will have one demand registration right to require the registration ofthe shares of Company common stock received by Long Hill in the Merger and Long Hill and Maxim will have certain piggyback registrationrights. In addition, Long Hill agreed with the Company that, during the applicable Restriction Period (as defined below), it shallnot sell or transfer, subject to certain limited exceptions, the portion of the shares received in the Merger during the applicableRestriction Period, subject to a limitation on the number of shares sold per any trading day not to exceed 10 % of the averagedaily trading volume of the Common Stock, as reported by Bloomberg Financial L.P. “Restriction Period” means (a) inrelation to 70% of all of the shares received in the Merger that Long Hill is entitled to receive under or in connection withthe Merger Agreement, the period beginning on the date of the closing and ending on the date that is the four month anniversarythereof, and (b) in relation to the remaining 30% of all of the shares received in the Merger that Long Hill is entitled to receiveunder or in connection with the Merger Agreement, the period beginning on the date of the closing and ending on the date thatis the twelve month anniversary thereof . All of the shares required to be registered by the Company pursuant to the RegistrationRights and Lock-Up Agreement were registered by the Company in November 2020.

Inaddition, pursuant to separate Lock-Up Agreements entered into by the Shareholders other than Long Hill with the Company (the“Shareholders Lock-Up Agreement”), such Shareholders agreed that they will not transfer any of their shares receivedin the Merger except in accordance with the following lock-up release schedule whereby one fifth of such holder’s respectiveshares will be released from such restriction every six months, starting six months from the closing of the Merger. Each holder’ssales of such shares are subject to a resale limit of its pro rata portion of 10% of the average daily trading volume, allocatedto the Shareholders other than Long Hill pro-rata.

Theacquisition was accounted in accordance with Accounting Standards Codification Topic 805, “Business Combinations”.The allocation of the consideration transferred in certain cases may be subject to revision based on the final determination offair values during the measurement period, which may be up to one year from the acquisition date. The Company includes the resultsof operations of the business that it has acquired in its consolidated results prospectively from the date of acquisition.

FairValue of Consideration Transferred

Thefollowing table summarizes the allocation of purchase price to the fair values of the assets acquired and liabilities assumedas of the transaction date:

SUMMARY OF ASSETS ACQUIRED AND LIABILITIES ASSUMED

		(in thousands)
		(in thousands)
Fair value of 8.8 % of shared issued *		*	11,172
Cash payment			1,115
Total consideration transferred		$	12,287

*	Fair value of the consideration is based on the company’s market share price.

F- 23

Total assets acquired:
Cash and cash equivalents		$	8
Restricted Cash			152
Accounts Receivable			228
Inventory			34
Other assets			25
Property, plants and equipment, net			482
Kyslecel Technology (a)	(a)		9,340
IPR&D (a)			641
Operating lease right-of-use assets			238
Goodwill (b)			3,704
Total assets			14,852
Total liabilities assumed:
Operating leases			238
Accounts Payable			216
Accrued Expenses			4
Orgenesis Inc loan			651
Deferred taxes			1,293
Notes Payable			162
Other liabilities			1
Total liabilities			2,565
Total consideration transferred		$	12,287

a.

The allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the recognition of other intangible assets which comprised of: Kyslecel Technology of $ 9,340 and IPR&D of 641 . Kyslecel Technology has a useful life of 15 years. The useful life of these intangible assets for amortization purposes was determined considering the period of expected cash flows generated by the assets used to measure the fair value of the intangible assets adjusted as appropriate for the entity-specific factors, including legal, regulatory, contractual, competitive, economic or other factors that may limit the useful life of intangible assets.

Theseintangible assets were estimated using a discounted cash flow method with the application of the multi-period excess earningsmethod. Under this method, an intangible asset’s fair value is equal to the present value of the incremental after-tax cashflows attributable only to the subject intangible asset after deducting contributory asset charges. An income and expenses forecastwere built based upon revenue and expense estimates.

b.	The primaryitems that generate goodwill include the value of the synergies between the acquired company and the Company and the acquiredassembled workforce, neither of which qualifies for recognition as an intangible asset. The Goodwill is not deductible for taxpurposes.

Proforma Impact of Business Combination

Theunaudited pro forma financial results have been prepared using the acquisition method of accounting and are based on the historicalfinancial information of the Company and Koligo. The unaudited pro forma condensed financial results have been prepared for illustrativepurposes only and do not purport to be indicative of the results of operations that actually would have resulted had the acquisitionof Koligo occurred at the beginning of the fiscal year, or of future results of the combined entities. The unaudited pro formacondensed financial information does not reflect any operating efficiencies and expected realization of cost savings or synergiesassociated with the acquisition.

Unauditedsupplemental pro forma combined results of operations (in thousands):

SCHEDULE OF UNAUDITED SUPPLEMENTAL PRO FORMA

		2020				2019
		Year ended December 31,
		2020				2019
Revenues		$	8,239			$	4,398
Net loss		$	318			$	27,263
Loss per share:
Basic		$	0.05			$	1.91

Koligo’srelated actual results from the date of acquisition to December 31, 2020 resulted in a loss of $ 513 thousand.

F- 24

Koligo’sAcquisition-related Costs

Acquisition-relatedexpenses consist of transaction costs which represent external costs directly related to the acquisition of Koligo and primarilyinclude expenditures for professional fees such as legal, accounting and other directly related incremental costs incurred toclose the acquisition by both the Company and Koligo.

Acquisition-relatedexpenses for the year ended December 31, 2020 were $ 682 thousand. These expenses were recorded to selling and general administrativeexpense in the consolidated statements of comprehensive loss.

Cooperatereorganization, description of the Transactions Korea and OBI during 2019

OnAugust 7, 2019, the Company, Masthercell Global and GPP-II Masthercell, LLC, a Delaware limited liability company (“GPP-II”),(the “Parties”) entered into a Transfer Agreement (the “Transfer Agreement”). As a result of the TransferAgreement, Masthercell Global transferred all of its equity interests of OBI and the Korean Subsidiary to Orgenesis Inc in exchangefor one dollar ($ 1.00 ). The Transfer Agreement also contained agreements made with respect to certain intercompany loans. TheCompany accounted for the Transfer Agreement as a transaction with non-controlling interest.

NOTE5 – PROPERTY, PLANTS AND EQUIPMENT

Thefollowing table represents the components of property, plants and equipment:

SCHEDULE OF COMPONENTS OF PROPERTY, PLANTS AND EQUIPMENT

		December 31,
		2020				2019
		(in thousands)
Cost:
Production facility		$	2,801			$	2,481
Office furniture and computers			697				606
Lab equipment			1,483				656
Advance payment			281				-
Subtotal			5,262				3,743
Less – accumulated depreciation			( 2,189	)			( 1,438	)
Total		$	3,073			$	2,305

Depreciationexpense for the years ended December 31, 2020 and December 31, 2019 were $ 705 thousand and $ 634 thousand, respectively.

Property,plants and equipment, net by geographical location were as follows:

SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT BY GEOGRAPHICAL LOCATION

		December 31,
		2020				2019
		(in thousands)
Belgium		$	358			$	-
Korea			839				983
Israel			1,386				1,322
U.S.			490				-
Total		$	3,073			$	2,305

F- 25

NOTE6 – INTANGIBLE ASSETS AND GOODWILL

Changesin the carrying amount of the Company’s goodwill for the years ended December 31, 2020 and 2019 are as follows:

SCHEDULE OF GOODWILL

		(in thousands)
Goodwill as of December 31, 2018		$	4,942
Goodwill as acquired, (Koligo) see note 4			-
Translation differences			( 130	)
Goodwill as of December 31, 2019		$	4,812
Goodwill as of December 31, 2019		$	4,812
Goodwill as acquired, (Koligo) see note 4			3,704
Translation differences			229
Goodwill as of December 31, 2020		$	8,745

GoodwillImpairment

SeeNote 2(m) for the Company’s goodwill impairment analysis.

OtherIntangible Assets

Otherintangible assets consisted of the following:

SCHEDULE OF OTHER INTANGIBLE ASSETS

		December 31,
		2020				2019
		(in thousands)
Gross Carrying Amount:
Know How		$	3,170			$	2,991
Customer relationships			886				895
Kyslecel Technology			9,340				-
IPR&D			641				-
Subtotal			14,037				3,886
Less – Accumulated amortization			( 1,014	)			( 538	)
Net carrying amount of other intangible assets		$	13,023			$	3,348

Intangibleassets amortization expenses were approximately $ 478 thousandand $ 430 thousand for the years ended December 31, 2020 and December 31, 2019, respectively.

Estimatedaggregate amortization expenses for the five succeeding years ending on December 31 ^st are as follows:

SCHEDULE OF ESTIMATED AGGREGATE AMORTIZATION EXPENSES

		2021				2022 to 2025
		(in thousands)
Amortization expenses		$	965			$	3,910

F- 26

NOTE7 – CONVERTIBLE LOANS

SCHEDULE OF LONG TERM CONVERTIBLE LOANS

a.	Long term convertible loans outstanding as of December 31, 2020 and December 31, 2019 are as follows:

Principal Amount				Issuance Year		Interest Rate				Maturity Period		Exercise Price				BCF
(in thousands)										(Years)
Convertible Loans Outstanding as of December 31, 2020
$	1,000			2018			2	%		3			7.00	(1)			71
	9,500			2019			6 %- 8	%		2 - 5			7.00	(2)			-
	250			2020			8	%		2			7.00	(3)			-
$	10,750
Convertible Loans Outstanding as of December 31, 2019
$	1,500			2018			2	%		3			7.00	(1)			124
	11,400			2019			6 %- 8	%		2 - 5			7.00	(2)			-
$	12,900

Convertible Loans repaid during the year ended December 31, 2020
Principal Amount				Issuance Year		Interest Rate				Maturity Period		Exercise Price				BCF
	500			2018			2	%		0.87		$	7				53
	500			2019			6	%		0.28			7				-
	1,400			2019			8	%		0.76			7				-
	2,400

Apartfrom the items mentioned below there were no repayments of convertible loans during the fiscal years ended December 31, 2019 andDecember 31, 2020. In addition, there were no conversions during the fiscal years ended December 31, 2019 and December 31,2020.

(1)

The holders,at their option, may convert the outstanding principal amount and accrued interest under this note into a total of 148,838 sharesand 148,838 three-year warrants to purchase up to an additional 148,838 shares of the Company’s common stock at a per shareexercise price of $ 7 . In the initial two years, the holders have the right to convert the outstanding principal amount and accruedinterest into shares of capital stock of Hemogenyx-Cell or Immugenyx, LLC according under the relevant note agreement, subsidiariesof Hemogenyx Pharmaceuticals Plc, at a price per share based on a pre-money valuation of Hemogenyx-Cell or Immugenyx, LLC of $ 12 million and $ 8 million, respectively, pursuant to the collaboration agreement with Hemogenyx Pharmaceuticals Plc and Immugenyx,LLC. As of December 31, 2020, the loans are presented in current maturities of convertible notes in the balance sheet (See Notes11(c) and 11(d).

(2)

The holders,at their option, may convert the outstanding principal amount and accrued interest under this note into a total of 1,443,734 sharesand 1,053,503 three-year warrants to purchase up to an additional 1,053,503 shares of the Company’s common stock at a pershare exercise price of $ 7 . As of December 31, 2020, $ 2,500 thousand of the principal amount is included in current maturitiesof convertible loans in the balance sheet and the remainder in long-term convertible loans. See also Notes 7(b), 7(c), 7(e), 7(f)and 7(g).

(3)

The holders,at their option, may convert the outstanding principal amount and accrued interest under this note into a total of 38,559 sharesat a per share exercise price of $ 7 . As of December 31, 2020, all the principal amount is included in long-term convertible loansin the balance sheet See also Notes 7(h).

b.During April 2019, the Company entered into a convertible loan agreement with an offshore investor for an aggregate amount of$ 500 thousand into the U.S. Subsidiary. The investor, at its option, may convert the outstanding principal amount and accruedinterest under this note into shares and three-year warrants to purchase shares of the Company’s common stock at a per shareexercise price of $ 7.00 ; or into shares of the U.S. Subsidiary at a valuation of the U.S. Subsidiary of $ 50 million. During February2020 the company repaid this convertible loan to the investor in full.

F- 27

c.During May 2019, the Company entered into a private placement subscription agreement with an investor for $ 5 million. The lendershall be entitled, at any time prior to or no later than the maturity date, to convert the outstanding amount, into units of (1)shares of common stock of the Company at a conversion price per share equal to $ 7.00 and (2) warrants to purchase an equal numberof additional shares of the Company’s common stock at a price of $ 7.00 per share.

Thetransaction costs were approximately $ 497 thousand, out of which $ 97 thousand are stock-based compensation due to issuance ofwarrants.

d.In May 2019, the Company had agreed to enter into a 6 % convertible loan agreement with an investor for an aggregate amount of$ 5 million. The lender shall be entitled, at any time prior to or no later than the maturity date, to convert the outstandingamount, into units of (1) shares of stock of the Company at a conversion price per share equal to $ 7.00 and (2) warrants to purchasean equal number of additional shares of the Company’s common stock at a price of $ 7.00 per share. As of the date of thefiling of this Annual Report on Form 10-K, the loan had not yet been received by the Company.

e.In June 2019, the Company entered into private placement subscription agreements with investors for an aggregate amount of $ 2 million. The lenders shall be entitled, at any time prior to or no later than the maturity date, to convert the outstanding amount,into units of (1) shares of common stock of the Company at a conversion price per share equal to $ 7.00 and (2) warrants to purchasean equal number of additional shares of the Company’s common stock at a price of $ 7.00 per share.

f.During October 2019, the Company entered into a Private Placement Subscription Agreement and Convertible Credit Line Agreement(collectively, the “Credit Line Agreements”) with four non-U.S. investors (the “Lenders”), pursuant towhich the Lenders furnished to the Company access to an aggregate $ 5 .0 million credit line (which consists of $ 1.25 million fromeach Lender) (collectively, the “Credit Line”). Pursuant to the Credit Line Agreements, the Company is entitled todraw down an aggregate of $ 1 million (consisting of $ 250 thousand from each Lender) of the Credit Line in each of October 2019and November 2019. In each of December 2019, January 2020 and February 2020, the Company may draw down an additional aggregateof $ 1 million (consisting of $ 250 thousand from each Lender), until the total amount drawn down under the Credit Line reachesan aggregate of $ 5 million (consisting of $ 1.25 million from each Lender), subject to the approval of the Lenders.

Pursuantto the terms of the Credit Line Agreements and the Notes, the total loan amount, and all accrued but unpaid interest thereon,shall become due and payable on the second anniversary of the Effective Date (the “Maturity Date”). The Maturity Datemay be extended by each Lender in its sole discretion and shall be in writing signed by the Company and the Lender. Interest onany amount that has been drawn down under the Credit Line accrues at a per annum rate of eight percent ( 8 %). At any time priorto or on the Maturity Date, by providing written notice to the Company, each of the Lenders is entitled to convert its respectivedrawdown amounts and all accrued interest, into shares of the Company’s common stock, par value $ 0.0001 per share (the “CommonStock”), at a conversion price equal to $ 7.00 per share.

Furthermore,upon the drawdown of $ 500 thousand from each Lender and, together with the other Lenders, a drawdown of an aggregate of $ 2 millionunder the Credit Line, the existing warrants of the Lenders to purchase shares of Common Stock shall be amended to extend theirexercise date to June 30, 2021 and the Company will issue to each of the Lenders warrants to purchase 50,000 shares of CommonStock at an exercise price of $ 7.00 per share. The new warrants will be exercisable for three ( 3 ) years from the Effective Date.During October 2019, such drawdown was reached and the warrants were issued. The modification of the existing warrants in theamount of $ 145 thousands was recorded against the accumulated deficit and the value of the new warrants in the amount of $ 370 thousands was offset against the convertible loan amount.

Thelender shall be entitled, at any time prior to or no later than the maturity date, to convert the outstanding amount, into unitsof shares of common stock of the Company at a conversion price per share equal to $ 7.00 .

Asat December 31, 2019, the Company had received $ 3.65 million from the Convertible CreditLine investment comprised of $ 1.15 million from one investor, $ 1 million from a second investor, and $ 750 thousand from two of the other lenders.

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Thetransaction costs were approximately $ 145 thousand.

Duringthe year ended December 2020 the company repaid principal amount of $ 2,400 thousand and a total interest amount of $ 372 thousandto certain of the credit line investors.

g.In December 2019, the Company entered into private placement subscription agreements with investors for an aggregate amount of$ 250 thousand. The lenders shall be entitled, at any time prior to or no later than the maturity date, to convert the outstandingamount, into units of 1 share of common stock of the Company at a conversion price per share equal to $ 7.00 and warrants to purchase 183,481 additional shares of the Company’s common stock at a price of $ 7.00 per share. The fair value of the warrants was$ 124 thousand using the fair value of the shares on the grant date.

h.On January 2, 2020, the Company entered into private placement subscription agreements with investors for an aggregate amountof $ 250 thousand of convertible loans. The lenders shall be entitled, at any time prior to or no later than the maturity date,to convert the outstanding amount, into shares of Common Stock of the Company at a conversion price per share equal to $ 7.00 .In addition, the Company granted the investors 151,428 warrants to purchase an equal number of additional shares of Common Stockat a price of $ 7.00 per share.

i.In December 2018, the Company entered into a Controlled Equity Offering Sales Agreement, or Sales Agreement, with Cantor Fitzgerald& Co., or Cantor, pursuant to which the Company may offer and sell, from time to time through Cantor, shares of its commonstock having an aggregate offering price of up to $ 25.0 million. The Company will pay Cantor a commission rate equal to 3.0 % ofthe aggregate gross proceeds from each sale. Shares sold under the Sales Agreement will be offered and sold pursuant to the Company’sShelf Registration Statement on Form S-3 (Registration No. 333-223777) that was declared effective by the Securities and ExchangeCommission on March 28, 2018, or the Shelf Registration Statement, and a prospectus supplement and accompanying base prospectusthat the Company filed with the Securities and Exchange Commission on December 20, 2018. The Company has not yet sold any sharesof its common stock pursuant to the Sales Agreement.

j.On November 2, 2016, the Company entered into unsecured convertible note agreements with accredited or offshore investors foran aggregate amount of NIS 1 million ($ 280 thousand). The loan bears a monthly interest rate of 2 % and mature on May 1, 2017 ,unless converted earlier. On April 27, 2017 and November 2, 2017, the Company entered into extension agreements through November2, 2017 and May 2, 2018, respectively.

InMarch 2018, the investor submitted a notice of its intention to convert into shares of the Company’s common stock the principalamount and accrued interest of approximately $ 383 thousand outstanding. A related party of such investor at the same time, exercisedwarrants issued in November 2016 to purchase shares of the Company’s Common Stock. The exercise price of the warrants andconversion price were fixed at $ 0.52 per share (pre-reverse stock split implemented by the Company in November 2017). There isa significant disagreement between the Company and these two entities as to the number of shares of Common Stock issuable to theseentities, and they contend that the number of shares of Common Stock issuable to them should not consider the reverse stock split.The Company rejects these contentions in their entirety and, based on the advice of specially retained counsel, believes thatthese claims are without legal merit and not made in good faith. The Company intends to vigorously defend its interests and pursueother avenues of legal address. Through its counsel, the Company has advised these entities that unless they withdraw their requestwithin a specified period, the Company will cancel the above referenced agreements and these parties’ right to receive anyshares of the Company’s Common Stock. In April 2018, the Company withdrew the agreements and deposited the shares in totalamount of 107,985 issued under those agreements and the principal amount and accrued interest of the loan in escrow account. Thedeposit of the principal amount and accrued interest presented as restricted cash in the balance sheet as of December 31, 2020.

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NOTE8 – LOANS

Termsof Short-term Loans

SCHEDULE OF LOANS

								December 31,
		Currency		Interest Rate				2020				2019
								(in thousands)
Short term loans		KRW			3.61	%		$	-			$	260
Short term loans		KRW			6.00	%			-				131
Short term loans		USD			1.00	%			145				-
								$	145			$	391

NOTE9 – LEASES

TheCompany leases research and development facilities, equipment and offices under finance and operating leases. For leases withterms greater than 12 months, the Company record the related asset and obligation at the present value of lease payments overthe term. Many of the leases include rental escalation clauses, renewal options and/or termination options that are factored intothe determination of lease payments when appropriate.

TheCompany’s leases do not provide a readily determinable implicit rate. Therefore, the Company estimated the incremental borrowingrate to discount the lease payments based on information available at lease commencement.

Manufacturingfacilities

TheCompany leases space for its manufacturing facilities in Israel under operating lease agreements. The leasing contracts are fora period of 3 - 5 years.

Researchand Development facilities

TheCompany leases space for its research and development facilities in South Korea under an operating lease agreement. The leasingcontracts are for a period of 2 – 5 years.

Offices

TheCompany leases space for offices in Israel under operating leases. The leasing contracts are valid for terms of 5 years. Thesecontracts are considered as operational leasing and under operating lease right-of-use assets.

LeasePosition

Thetable below presents the lease-related assets and liabilities recorded on the balance sheet.

SCHEDULE OF LEASE-RELATED ASSETS AND LIABILITIES

		December 31, 2020
Assets
Operating Leases
Operating lease right-of-use assets		$	1,474
Finance Leases
Property, plants and equipment, gross			99
Accumulated depreciation			( 17	)
Property and equipment, net		$	82
Liabilities
Current liabilities
Current maturities of operating leases		$	485
Current maturities of long-term finance leases		$	19
Long-term liabilities
Non-current operating leases		$	1,020
Long-term finance leases		$	64
Weighted Average Remaining Lease Term
Operating leases			3.4 years
Finance leases			4.2 years
Weighted Average Discount Rate
Operating leases			6.7	%
Finance leases			2.0	%

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LeaseCosts

Thetable below presents certain information related to lease costs and finance and operating leases during the year ended December31, 2020.

SCHEDULE OF LEASE COSTS

		Year ended December 31, 2020
Operating lease cost:		$	547
Finance lease cost:
Amortization of leased assets			17
Interest on lease liabilities			3
Total finance lease cost		$	20

Thetable below presents supplemental cash flow information related to leases during the year ended December 31, 2020:

SCHEDULE OF SUPPLEMENTAL CASHFLOW INFORMATION

		Year ended December 30, 2020
		(in Thousands)
Cash paid for amounts included in the measurement of leases liabilities:
Operating leases		$	515
Finance leases		$	42
Right-of-use assets obtained in exchange for lease obligations:
Operating leases		$	967
Finance leases			366

UndiscountedCash Flows

Thetable below reconciles the undiscounted cash flows for each of the first five years and total of the remaining years to the financelease liabilities and operating lease liabilities recorded on the balance sheet.

SCHEDULE OF FINANCE LEASE LIABILITIES AND OPERATING LEASE LIABILITIES

		Operating Leases				Finance Leases
Year ended December 31,
2021		$	526			$	20
2022			528				20
2023			342				20
2024			188				20
2025			59				4
Total minimum lease payments			1,643				84
Less: amount of lease payments representing interest			( 138	)			( 1	)
Present value of future minimum lease payments			1,505				83
Less: Current leases obligations			( 485	)			( 19	)
Long-term leases obligations		$	1,020			$	64

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Right-of-useassets by geographical location were as follows:

SCHEDULE OF RIGHT-OF-USE ASSETS BY GEOGRAPHICAL LOCATION

		December 31,
		2020				2019
		(in thousands)
Korea		$	683			$	145
Israel			496				580
U.S.			295				-
Total		$	1,474			$	725

NOTE10 – COMMITMENTS

SeeNote 11 for additional commitments for funding of the ventures of the company.

a.	Maryland Technology Development Corporation

OnJune 30, 2014, the Company’s U.S. Subsidiary entered into a grant agreement with Maryland Technology Development Corporation(“TEDCO”). TEDCO was created by the Maryland State Legislature in 1998 to facilitate the transfer and commercializationof technology from Maryland’s research universities and federal labs into the marketplace and to assist in the creationand growth of technology-based businesses in all regions of the State. Under the agreement, TEDCO paid to the U.S Subsidiary anamount of $ 406 thousand (the “Grant”). On June 21, 2016 TEDCO has approved an extension until June 30, 2017.

b.	Department De La Gestion Financiere Direction De L’analyse Financiere (“DGO6”)

(1)On November 17, 2014, the Belgian Subsidiary, received the formal approval from the DGO6 for a Euro 2 million ($ 2.4 million) supportprogram for the research and development of a potential cure for Type 1 Diabetes. The financial support was composed of Euro 1,085 thousand ( 70 % of budgeted costs) grant for the industrial research part of the research program and a further recoverable advanceof Euro 930 thousand ( 60 % of budgeted costs) of the experimental development part of the research program. In December 2014, theBelgian Subsidiary received advance payment of Euro 1,209 thousand under the grant. The grants are subject to certain conditionswith respect to the Belgian Subsidiary’s work in the Walloon Region. In addition, the DGO6 is also entitled to a royaltyupon revenue being generated from any commercial application of the technology. In 2017 the Company received by the DGO6 finalapproval for Euro 1.8 million costs invested in the project out of which Euro 1.2 million funded by the DGO6. As of December 31,2020, the Company repaid to the DGO6 a total amount of $ 118 thousand (Euro 96 thousand) and amount of $ 106 thousand was recordedin other payables.

(2)In April 2016, the Belgian Subsidiary received the formal approval from DGO6 for a Euro 1.3 million ($ 1.5 million) support program for the developmentof a potential cure for Type 1 Diabetes. The financial support was awarded to the Belgium Subsidiary as a recoverable advancepayment at 55 %of budgeted costs, or for a total of Euro 717 thousand ($ 800 thousand). The grant will be paid overthe project period. The Belgian Subsidiary received advance payment of Euro 438 thousand ($ 537 thousand). Up through December 31,2020, an amount of Euro 358 thousand ($ 437 thousand) was recorded as deduction ofresearch and development expenses and an amount of Euro 80 thousand was recorded as advance paymentson account of grant.

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(3)On October 8, 2016, the Belgian Subsidiary received the formal approval from the DGO6 for a Euro 12.3 million ($ 12.8 million)support program for the GMP production of AIP cells for two clinical trials that will be performed in Germany and Belgium. Theproject will be conducted during a period of three years commencing January 1, 2017. The financial support is awarded to the Belgiumsubsidiary at 55 % of budgeted costs, a total of Euro 6.8 million ($ 7 million). The grant will be paid over the project period.On December 19, 2016, the Belgian Subsidiary received a first payment of Euro 1.7 million ($ 2 million). Up through December 31,2020, an amount of Euro 1.7 million was recorded as deduction of research and development expenses and an amount of Euro 53 thousandwas recorded as receivable on account of grant.

(4)In December 2020, the Belgian Subsidiary received the formal approval from DGO6 for a Euro 2.9 million ($ 3.5 million) supportprogram for research on Dermatitis Treatments and Wound Healing Using Cell Regenerative Technologies. The financial support wasawarded to the Belgium Subsidiary as a recoverable advance payment at 60 % of budgeted costs, or for a total of Euro 1.7 million($ 2.1 million). The grant will be paid over the project period. The Belgian Subsidiary received an advance payment of Euro 301 thousand ($ 366 thousand) in December 2020. The research program is to be started in 2021.

c.	Israel-U.S. Binational Industrial Research and Development Foundation (“BIRD”)

OnSeptember 9, 2015, the Israeli Subsidiary entered into a pharma Cooperation and Project Funding Agreement (CPFA) with BIRD andPall Corporation, a U.S. company. BIRD awarded a conditional grant of $ 400 thousand each (according to terms defined in the agreement),for a joint research and development project for the use Autologous Insulin Producing (AIP) Cells for the Treatment of Diabetes(the “Project”). The Project started on March 1, 2015. Upon the conclusion of product development, the grant shallbe repaid at the rate of 5 % of gross sales. The grant will be used solely to finance the costs to conduct the research of theproject during a period of 18 months starting on March 1, 2015. On July 28, 2016, BIRD approved an extension for the project perioduntil May 31, 2017 and the final report was submitted to BIRD. As of December 31, 2020, the Israeli Subsidiary received a totalamount of $ 299 thousand under the grant and the project was completed.

d.	Korea-Israel Industrial Research and Development Foundation (“KORIL”)

OnMay 26, 2016, the Israeli Subsidiary and the Korean Subsidiary entered into a pharma Cooperation and Project Funding Agreement(CPFA) with KORIL. KORIL will give a conditional grant of up to $ 400 thousand each (according to terms defined in the agreement),for a joint research and development project for the use of AIP Cells for the Treatment of Diabetes (the “Project”).The Project started on June 1, 2016. Upon the conclusion of product development, the grant shall be repaid at the yearly rateof 2.5 % of gross sales. The grant will be used solely to finance the costs to conduct the research of the project during a periodof 18 months starting. On July 26, 2018 KORIL approved extension for the project period till May 31, 2019 and was further extendedto May 2020. During 2019, the grant was assigned to Cure Therapeutics from the Korean Subsidiary. As of December 31, 2020, theIsraeli Subsidiary and the Korean Subsidiary received $ 440 thousand under the grant.

e.	BIRD Secant

OnJuly 30, 2018, Orgenesis Inc and OBI entered into a collaboration agreement with Secant Group LLC (“Secant”). Underthe agreement, Secant will engineer and prototype 3D scaffolds based on novel biomaterials and technologies involving bioresorbablepolymer microparticles, while OBI will provide expertise in cell coatings, cell production, process development and support services.Under the agreement, Orgenesis is authorized to utilize the jointly developed technology for its autologous cell therapy platform,including its Autologous Insulin Producing (“AIP”) cell technology for patients with Type 1 Diabetes, acute pancreatitisand other insulin deficient diseases. In the beginning of 2018, OBI entered into a Cooperation and Project Funding Agreement (CPFA)with BIRD and Secant. BIRD will give a conditional grant up to $ 450 thousand each to support the joint project (according to termsdefined in the agreement).

Asof December 31, 2020, OBI received a total amount of $ 425 thousand under the grant. For the year ended December 31, 2020, an amountof $ 28 thousand was recorded as deduction of research and development expenses.

NOTE11 – COLLABORATION AND LICENSE AGREEMENTS

a.	Adva Biotechnology Ltd.

OnJanuary 28, 2018, the Company and Adva Biotechnology Ltd. (“Adva”), entered into a Master Services Agreement (“MSA”),under which the Company and/or its affiliates are to provide certain services relating to development of products to Adva, asmay be agreed between the parties from time to time. Under the MSA, the Company undertook to provide Adva with in kind fundingin the form of materials and services having an aggregate value of approximately $ 760 thousand at the Company’s own costin accordance with a project schedule and related mutually acceptable project budget. The Company entered into an agreement withOrgenesis Biotech Israel (previously Atvio), to fulfill its obligations pursuant this MSA and it completed its contractual obligationsunder the contract during 2019.

Inconsideration for and subject to the fulfillment by the Company of such in-kind funding commitment, Adva agreed that upon completionof the development of the products, the Company and/or its affiliates and Adva shall enter into a supply agreement pursuant towhich for a period of eight (8) years following execution of such supply agreement, the Company and/or its affiliates (as applicable)is entitled (on a non-exclusive basis) to purchase the products from Adva at a specified discount pricing from their then standardpricing. The Company and/or its affiliates were also granted a non-exclusive worldwide right to distribute such products, directlyor indirectly. The MSA shall remain in effect for 10 years unless earlier terminated in accordance with its terms.

b.	Tel Hashomer Medical Research, Infrastructure and Services Ltd (“THM”).

OnFebruary 2, 2012, the Company’s Israeli Subsidiary entered into a licensing agreement with THM. According to the agreement,the Israeli Subsidiary was granted a worldwide, royalty bearing, exclusive license to trans-differentiation of cells to insulinproducing cells, including the population of insulin producing cells, methods of making this population, and methods of usingthis population of cells for cell therapy or diabetes treatment developed by Dr. Sarah Ferber of THM.

Asconsideration for the license, the Israeli Subsidiary will pay the following to THM:

	1)	A royalty of 3.5 % of net sales;
	2)	16 % of all sublicensing fees received;
	3)	An annual license fee of $ 15 thousand, which commenced on January 1, 2012 and shall be paid once every year thereafter. The annual fee is non-refundable, but it shall be paid each year against the royalty noted above, to the extent that such are payable, during that year; and
	4)	Milestone payments as follows:
			a.	$ 50 thousand on the date of initiation of Phase I clinical trials in human subjects;
			b.	$ 50 thousand on the date of initiation of Phase II clinical trials in human subjects;
			c.	$ 150 thousand on the date of initiation of Phase III clinical trials in human subjects;
			d.	$ 750 thousand on the date of initiation of issuance of an approval for marketing of the first product by the FDA; and
			e.	$ 2 million when worldwide net sales of Products (as defined in the agreement) have reached the amount of $ 150 million for the first time, (the “Sales Milestone”).

Asof December 31, 2020, the Israeli Subsidiary had not reached any of these milestones.

Inthe event of closing of an acquisition of all of the issued and outstanding share capital of the Israeli Subsidiary and/or consolidationof the Israeli Subsidiary or the Company into or with another corporation (“Exit”), the THM shall be entitled to choosewhether to receive from the Israeli Subsidiary a one-time payment based, as applicable, on the value of either 463,651 sharesof common stock of the Company at the time of the Exit or the value of 1,000 shares of common stock of the Israeli Subsidiaryat the time of the Exit.

F- 34

c.	Hemogenyx Pharmaceuticals PLC.

OnOctober 18, 2018, the Company and Hemogenyx Pharmaceuticals PLC., a corporation with its registered office in the United Kingdomand Hemogenyx-Cell (“H-Cell”), a corporation with its registered office in Belgium (together “Hemo”),who are engaged in the development of cell replacement bone marrow therapy technology, entered into a Collaboration Agreement(the “Hemo Agreement”) pursuant to which the parties will collaborate in the funding, continued development, and commercializationof the Hemo technology via Hemo. Pursuant to the Hemo agreement the Company and Hemogenyx LLC (“Hemo-LLC”) (a whollyowned US subsidiary of Hemo) entered into a loan agreement on November 7, 2018 according to which the Company agreed to loan Hemo-LLCnot less than $ 1 million by way of a convertible loan.On November 25, 2018 the Company and Hemo entered into a License and Distribution agreement according to which Company receivedthe worldwide rights to market the products under the agreement in consideration for the payment of a 12 %royalty all subject to the terms of the agreement. On November 25, 2018, the Company and H-Cell signed an Exclusive Manufacturingagreement according to which the Company will receive the exclusive right to manufacture certain of H-Cell products. During 2018and 2020 the Company advanced $ 0.75 million and $ 0.25 million, respectively, to Hemo as a convertible loan and the entire loan was charged to expenses under ASC 730-10-50 and 20-50 and presented as researchand development costs.

SeeNote 7.

d.	Immugenyx LLC.

OnOctober 16, 2018, the Company and Immugenyx LLC., a corporation with its registered office in the USA (“Immu”), whois engaged in the development of technology related to the production and use of humanized mice entered into a Collaboration Agreement(the “Immu Agreement”) pursuant to which the parties will collaborate in the funding, continued development, and commercializationof the Immu technology. Pursuant to the agreement, the Company received the worldwide rights to market the products under theagreement in consideration for the payment of a 12 %royalty all subject to the terms of the agreement. Pursuant to the Immu agreement the Company and Immu entered into a loan agreementon November 7, 2018 according to which the Company agreed to loan Immu not less than US$ 1 Million by way of a convertible loan.During 2018 and 2020 the Company advanced $ 0.75 million and $ 0.25 million, respectively, to Immu as a convertible loan and the entire loan was charged to expenses under ASC 730-10-50 and 20-50 and presented as researchand development

e.	BG Negev Technologies and Applications (“BGN”).

OnAugust 2, 2018, the Company’s U.S. Subsidiary entered into a licensing agreement with BGN. According to the agreement, theU.S. Subsidiary was granted a worldwide, royalty bearing, exclusive license to develop and commercialize a novel alginate scaffoldtechnology for cell transplantation focused on autoimmune diseases.

OnNovember 25, 2018, the Company’s U.S. Subsidiary entered into a further licensing agreement with BGN. According to the agreement,the U.S. Subsidiary was granted a worldwide, royalty bearing, exclusive license to develop and commercialize technology directedto RAFT modification of polysaccharides and use of a bioreactor for supporting cell constructs.

Asconsideration for the licenses, the U.S. Subsidiary will pay royalties of between 4 % and 7 % (subject to rate reductions to 5 %and 4 %, respectively, in specific circumstances) of net sales of the licensed product, sub-license fees of 20 % of sub-licenseincome received, license fees of $ 10,000 per year per license, and milestone and budget payments according to agreed upon workplans to BGN.

F- 35

f.	Collaboration Agreement with Tarus Therapeutics, Inc.

OnFebruary 27, 2019, the Company and Tarus Therapeutics Inc., a Delaware corporation, (“Tarus”) entered into a CollaborationAgreement (the “Tarus Agreement”) for the collaboration in the funding, development and commercialization of certaintechnologies, products and patents of Tarus in the areas of therapeutics for cancer and other diseases in the field of cell therapiesand their combination with checkpoint inhibitors comprised of Adenosine Receptor Antagonists. Under the terms of the Tarus Agreementand subject to final due diligence and approved financing of the Company, the Company and/or one or more qualified investors (the“Investors”) shall advance to Tarus a convertible loan in an amount of not less than $ 1,750 thousand and up to $ 3,000 thousand (the “Loan Agreement”). As of December 31, 2020, the loan agreements have not been concluded, nor has anyfinancing been made to Tarus. As part of such Loan Agreement, and subject to approval by the board of directors of the Company,the Investors shall have the right, within two years of the date of the Loan Agreement, to convert the outstanding convertibleloan into either (i) shares of Tarus at a price per share based on a pre- money valuation of $ 12,500 thousand or (ii) shares ofthe Company’s common stock at a price per share set in accordance with an approved financing of the Company, with such termsas approved by the Company in its sole discretion. In the event the Investors elect to convert into shares of the Company’scommon stock, the Company shall have the right upon notice to Tarus to receive the same number of shares of capital stock of Tarusthat the Investors would have received had the Investors converted their convertible loans into shares of Tarus. Further, as partof the Loan Agreement, the Company shall advance to Tarus up to $ 500 thousand within fourteen days of execution of the Loan Agreement.Subject to the closing of the Loan Agreement, the Company and/or the Investors shall have an option, exercisable by sending writtennotice to Tarus at any time through the second anniversary of the closing of the Loan Agreement, to invest additional funds inan amount of up to $ 1,250 thousand and not less than $ 500 thousand in Tarus. The Company will also have the right to appoint and/orreplace one member of board of directors of Tarus. Upon and subject to the execution of a definitive development and manufacturingagreement between the Company and Tarus (“Manufacturing and Supply Agreement”), the Company, or one or more of itsaffiliates, shall manufacture and supply to Tarus and any of its affiliates, licensees, assignees of interest all requirementsfor all cell therapy elements of any combination therapy incorporating the technology of Tarus. Following the conclusion of theclinical development stage of each product emanating from the technology of Tarus, the cell therapy component of any such productborne out of the technology of Tarus shall be exclusively supplied by the Company under the Manufacturing and Supply Agreement.If the Company and Tarus fail to sign such Manufacturing and Supply Agreement for any given Tarus product, Tarus shall pay theCompany an amount equal to four percent ( 4 %) of gross revenues derived by Tarus from such Tarus products.

Apartfrom the above, there was no activity in the Tarus collaboration.

g.	Sponsored Research and Exclusive License Agreement with Columbia University

EffectiveApril 2, 2019, the Company and The Trustees of Columbia University in the City of New York, a New York corporation, (“Columbia”)entered into a Sponsored Research Agreement (the “SRA”) whereby the Company will provide financial support for studyingthe utility of serological tumor marker for tumor dynamics monitoring. Under the terms of the SRA, the Company shall pay $ 300 thousand per year for three years, or for a total of $ 900 thousand, with payments of $ 150 thousand due every six months.

EffectiveApril 2, 2019, the Company and Columbia entered into an Exclusive License Agreement (the “Columbia License Agreement”)whereby Columbia granted to the Company an exclusive license to discover, develop, manufacture, sell, and otherwise distributecertain product in the field of cancer therapy. In consideration of the licenses granted under the Columbia License Agreement,the Company shall pay to Columbia (i) a royalty of 5 % of net sales of any product sold which incorporates a licensed Columbiapatent and (ii) 2.5 % of net sales of other products. In addition, the Company shall pay a flat $ 100 thousand fee to Columbia uponthe achievement of each regulatory milestone.

h.	IRB Approval for Liver Cell Collection

OnApril 29, 2019, the Company received Institutional Review Board (“IRB”) approval to collect liver biopsies from patientsat Rambam Medical Center located in Haifa, Israel for a planned study to confirm the suitability of liver cells for personalizedcell replacement therapy for patients with insulin-dependent diabetes resulting from total or partial pancreatectomy. The livercells are intended to be bio-banked for potential future clinical use.

Thegoal of the proposed study, entitled “Collection of Human Liver Biopsy and Whole Blood Samples from Type 1 Diabetes Mellitus(T1DM), Total or Partial Pancreatectomy Patients for Potential use as an Autologous Source for Insulin Producing Cells in FutureClinical Studies,” is to confirm the suitability of the liver cells for personalized cell replacement therapy, as well aseligibility of patients to participate in a future clinical study, as defined by successful AIP cell production from their ownliver biopsy. The secondary objective of the study is to evaluate patients’ immune response to AIPs based on the patient’sblood samples and followed by subcutaneous implantation into the patients’ arm which would represent the first human trial.The Company has developed a novel technology based on technology licensed from Tel Hashomer Medical Research Infrastructure andServices Ltd., utilizing liver cells as a source for AIP cells as replacement therapy for islet transplantation.

Duringthe study, liver samples will be collected and then processed and stored in specialized, clinical grade, tissue banks for potentialclinical use. The propagated cells will be maintained in a tissue bank and are intended to be utilized in a future clinical study,in which the cells will be transdifferentiated and administered back to the patients as a potential treatment. This personalizedautologous process will be performed under our POC platform in which the patient liver samples are processed, cryopreserved andpotentially re-injected, all in the medical center under clinical grade/GMP level conditions.

F- 36

InJune 2019, the Company received additional Institutional Review Board (“IRB”) approval to collect liver biopsies frompatients at a leading medical center in USA for a planned study to confirm the suitability of liver cells for personalized cellreplacement therapy for patients with insulin-dependent diabetes resulting from total pancreatectomy (the granted Orphan DrugDesignation indication). The liver cells are intended to be bio-banked at the New York Blood Center, NYC for potential futureclinical use. In October 2019, a liver sample from the first recruited patient was collected and processed and stored at the NewYork Blood Center, NYC in specialized, clinical grade, tissue banks for potential clinical use.

i.	FDA Approval for Orphan Drug Designation for AIP Cells

OnJune 11, 2019, the FDA granted Orphan Drug Designation for the Company’s AIP cells as a cell replacement therapy for thetreatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy (“TP”) due to chronic pancreatitis.The incidence of diabetes following TP is 100 %, resulting in immediate and lifelong insulin-dependence with the loss of both endogenousinsulin secretion and that of the counter-regulatory hormone, glucagon. Glycemic control after TP is notoriously difficult withconventional insulin therapy due to complete insulin dependence and loss of glucagon-dependent counter-regulation. Patients withthis condition experience both severe hyperglycemic and hypoglycemic episodes.

j.	Regents of the University of California

InDecember 2019, the Company and the Regents of the University of California (“University”) entered into a joint researchagreement in the field of therapies and processing technologies according to an agreed upon work plan. According to the agreement,the Company will pay the University royalties of up to 5 % (or up to 20 % of sub-licensing sales) in the event of sales that includescertain types of University owned IP.

k.	Caerus Therapeutics Inc (a related party)

InOctober 2019, the Company and Caerus Therapeutics (“Caerus”), a Virginia company, concluded a license agreement wherebyCaerus granted the Company an exclusive license to all Caerus IP relating to Advance Chemeric Antigen Vectors for Targeting Tumorsfor the development and/or commercialization of certain licensed products. In consideration for the License granted to the Companyunder this Agreement, the Company shall pay Caerus feasibility fees (including the grant to purchase 70,000 options in the Company,annual maintenance fees and royalties of sales of up to 5 % and up to 18 % of sub-license fees. Expenses in the amount of approximately$ 200 thousand including the fair value of the options granted were recorded as research and development expenses. The Companyalso has the right to instruct Caerus to transfer the license, development, development results and any other rights and licensesgranted to the Company to a joint venture (“JV”) in which Company shall have a 51 % controlling ownership stake inthe JV Entity. Upon Company’s election of such option, the development shall be carried out by Caerus for the JV and theroyalty, sublicense fees and annual maintenance fee shall be terminated. Company may provide requisite funding for the JV Entityas determined by the Company and Caerus.

l.	Extracellular Vesicle (“EV”) Technology License

Duringthe third quarter of 2020, the Company purchased the IP and related EV technology from a service provider (the “ServiceProvider”) pursuant to an EV agreement (the “EV agreement”). According to the EV agreement, the Service Providersold to the Company all of its rights in the EV technology that it had produced, in the amount of $500 thousand, to be paid ininstallments over the next 12 months from September 2020. The $ 500 thousand was recorded in R&D expenses. In addition, theService Provider granted the Company an exclusive worldwide license to use the EV IP technology for any purpose.

F- 37

m.	Tamir Biotechnology acquisition

Includedin the purchased assets of the Tamir Biotechnology Inc acquisition (See Note 4) was the assumption by the Company of a worldwidelicense to a private company of certain Tamir technologies in the field of treatment, amelioration, mitigation or prevention ofdiseases or conditions of the eye and its adnexa in return for certain development and sales milestone payments to be paid toTamir. This license fee and the right to receive future milestone payments (of up to $ 11 million assuming that certain milestonesare reached) and royalties (of up to $ 35 million based on net sales milestones), were assumed by the Company in connection withthe Tamir Purchase Agreement together with a less than 10 % share interest. To date, no milestones have been reached.

n.	Tissue Genesis, LLC (“Tissue Genesis”)

Includedin the Koligo acquisition (See Note 4) were the assets of Tissue Genesis. The Company is committed to paying the previous ownersof Tissue Genesis up to $ 500 thousand upon the achievement of certain performance milestones and earn-out payments on future salesprovided that in no event will the aggregate of the earn-out payments exceed $ 4 million. To date, no milestones have been reached.

o.	Joint venture agreements

Additionally,the Company has entered into joint venture agreements (“JVAs”) with its joint venture partners (Company and partnerare referred to as “parties”) to facilitate the collaboration in the field of CGT development and development of theCompany’s worldwide POCare network. The provisos and the table below summarize the major agreements. CGT and POCare activitiescovered by the JVAs include the development, marketing, clinical development, and commercialization of the Company’s and/ or partner’s products within defined territories. The extent of the collaboration is set out in each agreement.

Unlessotherwise stated in the table below the JVAs include the following provisos (“Provisos”):

1.	The incorporation of a joint venture entity (“JVE”) in which the Company will hold between 49 % and 50 % of the equity.
2.	The partner will manage the joint venture activities until the JVE is incorporated.
3.	The JVE will be managed by a steering committee consisting of 3 members which will act as the entity’s board of directors. The Company is entitled to appoint 1 member, the partner is entitled to appoint 1 member, and Company and partner will jointly appoint the third member.
4.	The Company has the right to exercise a call option to acquire the partner’s share in the JVE based on the occurrence of certain events and according to an agreed upon mechanism.
5.	The funding of the parties’ investment in the joint venture share may be made in the form of cash investment and / or in-kind services. The Company’s cash investment may be in the form of additional shares, a convertible loan, and/or procured services.
6.	Each of the parties may agree to provide additional funding to the JVE to cover the operation costs and such additional funding may be in the form of in-kind contributions. The Company’s investments may be made in the form of a cash investment for additional shares, a convertible loan, and/or procured services. Procured services refer to certain services that the Company has engaged the partner or the JVE to provide the Company with, in support of Company’s activity. All results of these procured services shall be owned by Company.
7.	As appropriate, the parties will grant to the JVE an exclusive or nonexclusive, sublicensable, royalty-bearing, right and license to the relevant party’s background IP as required solely to manufacture, distribute and market and sell the party’s products within the territory. Each party shall receive royalties in an amount of ten percent ( 10 %) of the net sales generated by the JVE and/or its sublicensees.
8.	Once the JVE is profitable, the Company will be entitled (in addition to any of its rights as the holder of the JVE) to an additional share of fifteen percent ( 15 %) of the JVE’s GAAP profit after tax, over and above all rights granted pursuant to Company’s participating interest in the JVE.

F- 38

Name of party (and country of origin)		Territory		Notes
Theracell Advanced Biotechnology		Greece, Turkey, Cyprus, Israel and Balkans		(1)
Broaden Bioscience and Technology Corp		Certain projects in China and the Middle East
Mircod LLC (US)		Russia		(2)
Image Securities FZC (UAE) (a related party)		India
Cure Therapeutics		Korea and Japan
Kidney Cure Ltd		Worldwide		(3)
Sescom Ltd		Worldwide		(4)
Educell D.O.O (Slovenia)		Croatia, Serbia and Slovenia
Med Centre for Gene and Cell Therapy FZ-LLC (UAE)		UAE
Mida Biotech B.V. (Netherlands)		Netherlands, Lithuania, Spain, Switzerland, Germany, Belgium or any other countries within West Europe		(5)
First Choice International Company, Inc		Panama and certain other Latin American countries		(6)
KinerjaPay Corp		Singapore		(7)
SBH Sciences Inc		Worldwide		(8)
HekaBio KK		Japan		(9)

(1)	The Theracell JVE was incorporated in Greece under the name of Theracell Laboratories Ltd. (See Note 12).
(2)	Under the Mircod JVA, provisos 7 and 8 do not apply. Subject to payment by the Company ORGS of the contribution amount, the JVA will grant Company an exclusive, perpetual, irrevocable, royalty free and fully paid up and sublicensable license to use the Project IP for research and development and for the manufacturing, processing, supplying, and use of products based on point of care manufacturing and/or processing of treatments for patients and for use in hospitals, medical centers and academic institution settings solely outside the territory. The parties also, following proviso 6, concluded a convertible loan agreement pursuant to which Company shall lend Mircod up to $ 5 million based upon a development plan to be agreed upon. The loan bears simple interest in the amount of 6 % annually. As at December 31, 2020, the development plan had not been finalized and no transfers under the loan agreement were made.
(3)	Pursuant to the Kidney Cure JVA, the parties will collaborate in the (i) implementation of a point-of-care strategy; (ii) assessment of the options for development and manufacture of various cell-based types (including kidney derived cells, MSC cells, exosomes, gene therapies) development; and (iii) development of protocols and tests for kidney therapies (the “Project”). Provisos 7 and 8 do not apply to the Kidney Cure JVA. The Kidney Cure JVE was incorporated in Switzerland under the name of Butterfly Biosciences Sarl (See Note 12).
(4)	Under the Sescom JVA, the parties will collaborate in the field of the assessment of relevant tools and technologies to be used in the Company’s information security system (the “ISS”); (ii) the implementation of the ISS within the Company and in the Company’s point-of-care network; and (iii) the operation and maintenance of the ISS. Provisos 7 and 8 do not apply to this JVA. Company has agreed to provide the Sescom JVE with: (a) a non-exclusive, not transferable and non-sublicensable worldwide royalty-free license to use its background IP to the extent required for carrying out certain activities by the Sescom JVE; and (b) access to its point-of-care network and relevant data to be used for the certain activities.
(5)	Under the Mida JVA, commencing January 1, 2022 and thereafter Mida shall have the right to sell to Company its then issued and outstanding shares in the JVA, and if the JVA was not yet set up, its assets, contracts and liabilities relating to the project, for a consideration to be agreed between the parties in good faith, provided that such consideration is not lower than $ 500 thousand.
(6)	Under the First Choice JVA, each party shall, subject to fulfilment of the party’s JVA, grant the Panama JV Entity an exclusive license to certain intellectual property of the part to develop and commercialize the party’s products in the territory, subject to minimum sales obligations. In consideration of such license, the Panama JV shall pay the relevant part royalties at the rate of 15% of the Panama JVE net sales of party’s products sold in the territory.

F- 39

(7)	No activities have taken place since the JVA was signed. According to the JVA, Company was eligible to receive 51 % of the equity and 10 % royalties on sales of products. The steering committee was to compromise 5 members of which Company could appoint 2, and a third member to be an industry expert, to be appointed by Orgenesis. The JVA did not include the proviso 8.
(8)	Pursuant to the SBH JVA the parties will collaborate in the field of gene and cell therapy development, process and services of bio-exosome therapy products and services in the areas of diabetes, liver cells and skin applications, including wound healing. The SBH JVE has not yet been incorporated. According to the JVA, the board of directors of the SBH JVE shall be comprised of three directors with one appointed by SBH and two appointed by the Company. All intellectual property conceived or developed resulting from the business of the SBH JV Entity, that is not SBH’s or the Company’s background intellectual property, shall be owned exclusively by the SBH JV Entity, although the Company shall be granted the right to exclusively license any intellectual property arriving from the development activities of the SBH JV Entity, or exclusively distribute products based thereon. Provisos 7 and 8 do not apply to the SBH JVA.
	During the third quarter of 2019, the Company transferred $ 50 thousand to SBH. Apart from the above, there was no material activity in the SBH Collaboration and the SBH JV entity had not been incorporated as at December 31, 2020.
(9)	During the third quarter of 2020, the Company and HB agreed to terminate the license agreement. As of December 31, 2020, no activity had begun in the said JV and no investments were made therein.

NOTE12 – INVESTMENTS IN ASSOCIATES, NET

a.	Theracell Laboratories Private Company

DuringOctober 2020, the Company and Theracell, pursuant to the Greek JVA (See Note 11) incorporated the Greek JVA entity known as TheracellLaboratories Private Company (“TLABS”). The Theracell Project activities will be run through TLABS. The Company andTheracell each hold a 50 % participating interest in TLABS.

b.	Butterfly Biosciences Sarl

DuringOctober 2020, the Company and Kidney Cure, pursuant to the Kidney Cure JVA (See Note 11) incorporated the KC JV Entity known asButterfly Biosciences Sarl (“BB”) in Switzerland. BB will be involved in the (i) implementation of a point-of-carestrategy; (ii) assessment of the options for development and manufacture of various cell-based types (including kidney derivedcells, MSC cells, exosomes, gene therapies) development; and (iii) development of protocols and tests for kidney therapies (the“BB Project”). The Company holds a 49 % participating interest on BB and Kidney Cure holds the remaining 51 %.

c.	The table below sets forth a summary of the changes in the investments for the year ended December 31, 2020:

SCHEDULE OF CHANGES IN INVESTMENTS

		December 30,
		2020
		(In thousands)
Opening balance		$	-
Investments during the period			69
Share in net income of associated companies			106
Ending balance		$	175

F- 40

NOTE13 – EQUITY

a.	Financings

OnJanuary 20, 2020, the Company entered into a Securities Purchase Agreement (the “January Purchase Agreement”) withcertain investors pursuant to which the Company issued and sold, in a private placement (the “Offering”), 2,200,000 shares of Common Stock at a purchase price of $ 4.20 per share (the “Shares”) and warrants to purchase up to 1,000,000 shares of Common Stock at an exercise price of $ 5.50 per share (the “Warrants”) which are exercisable between June2021 and January 2023. The Company received gross proceeds of approximately $ 9.24 million before deducting related offering expensesin the amount of $ 0.8 million.

b.	Tamir Biotechnology, Inc.

Forthe acquisition of Tamir, see Note 4.

Asaggregate consideration for the acquisition, the Company paid $ 2.5 million in cash and issued an aggregate of 3,400,000 shares(the “Shares”) of Common Stock to Tamir resulting in a total consideration of $ 20.2 million based on the Company’sshare price at the closing date. $ 59 thousand and 340,000 Shares are being held in an escrow account for a period of 18 monthsfrom closing to secure indemnification obligations of Tamir pursuant to the terms of the Tamir Purchase Agreement. The share pricewas $ 5.26 at the day of the closing.

c.	Koligo Therapeutics Inc.

Forthe acquisition of Koligo, see Note 4.

Pursuantto the terms of the Merger Agreement, at the Effective Time, the shares of capital stock of Koligo that were issued and outstandingimmediately prior to the Effective Time were automatically cancelled and converted into the right to receive, subject to customaryadjustments, an aggregate of 2,063,713 shares of Company common stock whichhave been issued to Koligo’s accredited investors (with certain non-accredited investors being paid solely in cash inthe amount of approximately $ 20 thousand). In addition, we issued 66,910 shares to Maxim Group LLC for advisory services in connectionwith the Merger.

d.

Warrants

Asummary of the Company’s warrants granted to investors and as finder’s fees as of December 31, 2020, and December31, 2019 and changes for the periods then ended is presented below:

SCHEDULE OF WARRANTS ACTIVITY

		December 31,
		2020								2019
		Number of Warrants				Weighted Average Exercise Price $				Number of Warrants				Weighted Average Exercise Price $
Warrants outstanding at the beginning of the period			6,010,087				6.35				6,286,351				6.29
Changes during the period:
Issued			1,344,606				5.64				471,980				6.95
Expired			( 284,452	)			6.53				( 748,244	)			6.24
Warrants outstanding and exercisable at end of the period*	*		7,070,241				6.20				6,010,087				6.35

*	Asof December 31, 2020 and December 31, 2019, there are no warrants that are subject to exercise price adjustments.

F- 41

e.	Treasury shares

Asummary of the Company’s treasury shares purchased as of December 31, 2020 and changes for the period then ended is presentedbelow:

S CHEDULEOF TREASURY SHARES

		December 31,
		2020
		Number of Treasury Shares				Weighted Average Price Paid $
Treasury Shares at the beginning of the period			-				-
Changes during the period:
Purchased			55,309				4.47
Shares at end of the period			53,309				4.47

NOTE14 – INCOME (LOSS) PER SHARE

Thefollowing table sets forth the calculation of basic and diluted loss per share for the periods indicated:

SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE

		2020				2019
		Year ended December 31,
		2020				2019
		(in thousands, except per share data)
Basic and diluted:
Net loss from continuing operations attributable to Orgenesis Inc.		$	95,088			$	22,490
Net (income) loss from discontinued operations attributable to Orgenesis Inc. for loss per share			( 96,198	)			1,631
Adjustment of redeemable non-controlling interest to redemption amount			( 5,160	)			4,095
Basic: Net income (loss) available to common stockholders			( 101,358	)			5,726
Net (income) loss attributable to Orgenesis Inc. for loss per share			( 6,270	)			28,216
Weighted average number of common shares outstanding			21,320,314				15,907,995
Loss per common share from continuing operations		$	4.46			$	1.41
Net (income) loss common share from discontinued operations		$	( 4.75	)		$	0.36
Net (income) loss per share		$	( 0.29	)		$	1.77

Forthe year ended December 31, 2020, and December 31, 2019, all outstanding convertible notes, options and warrants have been excludedfrom the calculation of the diluted net loss per share since their effect was anti-dilutive. Diluted loss per share does not include 10,212,789 shares underlying outstanding options and warrants and 1,630,857 shares upon conversion of convertible loans for theyear ended December 31, 2020, because the effect of their inclusion in the computation would be anti-dilutive.

F- 42

NOTE15 – STOCK-BASED COMPENSATION

a.	Global Share Incentive Plan

OnMay 11, 2017, the annual meeting of the Company’s stockholders approved the 2017 Equity Incentive Plan (the “2017Plan”) under which, the Company had reserved a pool of 1,750,000 shares of the Company’s common stock, which may beissued at the discretion of the Company’s board of directors from time to time. Under this Plan, each option is exercisableinto one share of common stock of the Company. The options may be exercised after vesting and in accordance with the vesting schedulethat will be determined by the Company’s board of directors for each grant. The maximum contractual life term of the optionsis 10 years. At the Company’s annual meeting of stockholders on November 26, 2019 the Company’s stockholders approvedan amendment to increase the number of shares authorized for issuance of awards under the Company’s 2017 Equity IncentivePlan from 1,750,000 shares to an aggregate of 3,000,000 shares of Common Stock. As of December 31, 2020, total options grantedunder this plan are 1,362,133 and the total options that are available for grants under this plan are 1,724,966 .

OnMay 23, 2012, the Company’s board of directors adopted the Global Share Incentive Plan 2012 (the “2012 Plan”)under which, the Company had reserved a pool of 1,000,000 shares of the Company’s common stock, which may be issued at thediscretion of the Company’s board of directors from time to time. Under this plan, each option is exercisable into one shareof common stock of the Company. The options may be exercised after vesting and in accordance with the vesting schedule that willbe determined by the Company’s board of directors for each grant. The maximum contractual life term of the options is 10 years. As of December 31, 2020, total options granted under this plan are 1,183,182 and the total options that are available forgrants under this plan are 248,024 .

b.	Options Granted to Employees and Directors

Belowis a table summarizing all of the options grants to employees and Directors made during the years ended December 31, 2020, andDecember 31, 2019:

SCHEDULEOF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES

		Year Ended		No. of options granted				Exercise price				Vesting period		Fair value at grant (in thousands)				Expiration period
Employees		December 31, 2020			531,450				$ 2.99 -$ 6.84			Quarterly over a period of two years		$	1,312			10 years
Directors		December 31, 2020			145,050				$ 2.99 -$ 4.7			96 %on the one-year anniversary, andthe remaining 4 %in three equal instalments on the first, second and third year anniversaries		$	377			10 years
Employees		December 31, 2019			94,500				$ 3.14 -$ 5.07			Quarterly over a period of two years		$	322			10 years
Directors		December 31, 2019			50,000			$	2.99			One-year anniversary		$	103			10 years

Thefair value of each stock option grant is estimated at the date of grant using a Black Scholes option pricing model. The volatilityis based on historical volatility of the Company, by statistical analysis of the weekly share price for past periods based onexpected term. The expected option term is calculated using the simplified method , as the Company concludes that its historicalshare option exercise experience does not provide a reasonable basis to estimate its expected option term.

The fair value of eachoption grant is based on the following assumptions:

SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS

		Year Ended December 31,
		2020				2019
Value of one common share		$	2.99 -$ 6.84			$	2.99 -$ 5.07
Dividend yield			0	%			0	%
Expected stock price volatility			80 %- 86	%			83 %- 88	%
Risk free interest rate			0.36 %- 1.71	%			1.45 %- 2.47	%
Expected term (years)			5.50 - 6.00				5.38 - 5.56

F- 43

Asummary of the Company’s stock options granted to employees and directors as of December 31, 2020 and December 31, 2019is presented below:

SCHEDULE OF STOCK OPTIONS ACTIVITY

		Year Ended December 31
		2020								2019
		Number of Options				Weighted Average Exercise Price $				Number of Options				Weighted Average Exercise Price $
Options outstanding at the beginning of the period			2,465,522				4.44				2,376,427				4.51
Changes during the period:
Granted			676,500				3.74				144,500				4.15
Exercised			-				-				-				-
Expired			( 11,876	)			7.88				( 16,750	)			6.01
Forfeited			( 57,042	)			4.52				( 38,655	)			7.11
Cancelled			( 155,437	)			8.38				-				-
Options outstanding at end of the period			2,917,667				4.05				2,465,522				4.44
Options exercisable at end of the period			2,299,937				4.03				2,112,567				4.21

Thefollowing table presents summary information concerning the options granted and exercisable to employees and directors outstandingas of December 31, 2020 (in thousands, except per share data):

SCHEDULE OF STOCK OPTIONS EXERCISABLE

Exercise Price $				Number of Outstanding Options				Weighted Average Remaining Contractual Life				Aggregate Intrinsic Value $				Number of Exercisable Options				Aggregate Exercisable Options Value $
												(in thousands)								(in thousands)
	0.0012				230,189				3.64				1,036				230,189				-
	0.012				510,017				1.09				2,289				510,017				6
	2.99				445,013				9.15				672				174,208				521
	3.14				3,750				6.27				5				1,875				6
	4.42				50,000				6.93				4				50,000				221
	4.5				34,000				8.47				-				23,938				108
	4.6				185,300				9.96				-				-				-
	4.7				6,250				9.03				-				-				-
	4.8				483,337				5.94				-				483,337				2,320
	5.07				53,250				8.08				-				39,750				202
	5.1				63,000				9.68				-				7,875				40
	5.99				352,550				7.26				-				290,488				1,740
	6				16,667				3.59				-				16,667				100
	6.84				17,000				9.38				-				4,250				29
	7.2				83,334				6.43				-				83,334				600
	8.36				250,001				7.50				-				250,001				2,090
	8.91				15,000				7.46				-				15,000				134
	9				20,834				2.54				-				20,834				187
	9.48				58,908				1.52				-				58,908				558
	10.2				39,267				1.42				-				39,267				401
					2,917,667				5.98				4,006				2,299,937				9,263

Costsincurred with respect to stock-based compensation for employees and directors for the years ended December 31, 2020 and December31, 2019 were $ 1,470 thousand and $ 2,107 thousand, respectively, out of which $ 450 thousand and $ 360 thousand related to options granted to employees of Masthercell Global, respectively, and presented as part of net loss from discontinuedoperations in the consolidated statements of comprehensive loss. As of December 31, 2020, there was $ 1,594 thousands of unrecognized compensationcosts related to non-vested employees and directors stock options, to be recorded over the next 2.02 years.

F- 44

c.	Options Granted to Consultants and service providers

Belowis a table summarizing all the compensation granted to consultants and service providers during the years ended December 31, 2020and December 31, 2019 and for the one-month period ended December 31, 2019:

SCHEDULE OF STOCK OPTIONS GRANTED TO CONSULTANTS

		Year of grant		No. of options granted				Exercise price				Vesting period		Fair value at grant (in thousands)				Expiration period
Non-employees		2020			62,500			$	2.99 -$ 6.84			Quarterly over a period of two years		$	209			10 years
Non-employees		2019			128,336			$	3.14 -$ 7			Vest immediately- 5 years		$	394			10 years

Thefair value of options granted during 2020 and 2019 to consultants and service providers, was computed using the Black-Scholesmodel. The fair value of each stock option grant is estimated at the date of grant using a Black Scholes option pricing model.The volatility is based on historical volatility of the Company, by statistical analysis of the weekly share price for past periodsbased on the expected term period, the expected term is the contractual term of each grant.

The underlying data used for computingthe fair value of the options are as follows:

SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS

		Year Ended December 31,
		2020				2019
Value of one common share		$	2.99 -$ 6.84			$	3.14 -$ 5.07
Dividend yield			0	%			0	%
Expected stock price volatility			86 %- 89	%			89 %- 92	%
Risk free interest rate			0.73 %- 1.12	%			1.52 %- 2.62	%
Expected term (years)			10				10

Asummary of the Company’s stock options granted to consultants and service providers as of December 31, 2020, and December31, 2019 is presented below:

SCHEDULE OF STOCK OPTIONS ACTIVITY

		Year Ended December 31,
		2020								2019
		Number of Options				Weighted Average Exercise Price $				Number of Options				Weighted Average Exercise Price $
Options outstanding at the beginning of the year			598,310				5.76				469,974				5.75
Changes during the year:
Granted			62,500				3.97				128,336				5.65
Exercised			( 83,334	)			3.60				-				-
Forfeited			( 8,335	)			5.99				-				-
Cancelled			( 20,000	)			5.30				-				-
Options outstanding at end of the year			549,141				5.89				598,310				5.76
Options exercisable at end of the year			450,972				6.28				539,515				5.88

F- 45

Thefollowing table presents summary information concerning the options granted and exercisable to consultants and service providersoutstanding as of December 31, 2020 (in thousands, except per share data):

SCHEDULE OF STOCK OPTIONS EXERCISABLE

Exercise Price $				Number of Outstanding Options				Weighted Average Remaining Contractual Life				Aggregate Intrinsic Value* $				Number of Exercisable Options				Aggregate Exercisable Options Value $
												(in thousands)								(in thousands)
	2.99				35,000				9.22				53				-				-
	3.14				15,000				8.91				20				-				-
	3.36				136,775				5.32				156				136,775				460
	4.09				25,000				8.76				10				25,000				102
	4.42				10,325				6.93				1				10,325				46
	4.5				13,335				8.53				-				-				-
	4.6				20,000				9.96				-				-				-
	4.8				16,668				5.94				-				16,668				80
	5.07				5,000				8.19				-				1,000				5
	5.3				15,000				7.70				-				15,000				80
	5.99				16,670				7.81				-				16,670				100
	6				90,000				3.59				-				90,000				540
	6.84				7,500				9.38				-				-				-
	7				70,000				8.83				-				70,000				490
	7.32				8,334				1.89				-				8,334				61
	8.34				8,600				7.52				-				8,600				72
	8.43				8,333				7.05				-				4,999				42
	11.52				8,334				2.26				-				8,334				96
	16.8				39,267				1.28				-				39,267				660
					549,141				6.18				240				450,972				2,834

Costsincurred with respect to options granted to consultants and service providers for the years ended December 31, 2020 and December31, 2019 were $ 113 thousand and $ 330 thousand, respectively. As of December 31, 2020, there was $ 231 thousands of unrecognizedcompensation costs related to non-vested consultants and service providers, to be recorded over the next 4.58 years.

d.	Warrants and Shares Issued to Non-Employees

Thefair value of Common Stock issued was the share price of the shares issued at the day of grant.

1)On January 20, 2020, the Company entered into a Securities Purchase Agreement (the “January Purchase Agreement”) withcertain investors pursuant to which the Company issued and sold, in a private placement (the “Offering”), 2,200,000 shares of Common Stock at a purchase price of $ 4.20 per share (the “Shares”) and warrants to purchase up to 1,000,000 shares of Common Stock at an exercise price of $ 5.50 per share (the “Warrants”) which are exercisable between June2021 and January 2023. The Company received gross proceeds of approximately $ 9.2 million before deducting related offering expensesin the amount of $ 0.8 million. The fair value of those warrants as of the date of grant using the Black-Scholes valuation modelwas $ 1,911 thousand.

2)On January 2, 2020, the Company entered into private placement subscription agreements with investors for an aggregate amountof $ 250 thousand of convertible loans. The lenders shall be entitled, at any time prior to or no later than the maturity date,to convert the outstanding amount, into shares of Common Stock of the Company at a conversion price per share equal to $ 7.00 .In addition, the Company granted the investors 151,428 warrants to purchase an equal number of additional shares of the Company’sCommon Stock at a price of $ 7.00 per share. The fair value of those warrants as of the date of grant using the Black-Scholes valuationmodel was $ 210 thousand.

3)During the year ended December 31, 2020, the Company granted to several consultants 193,178 warrants each exercisable between$ 3.14 and $ 5.34 per share for three years . The fair value of those options as of the date of grant using the Black-Scholes valuationmodel was $ 378 thousand, out of which $ 350 thousand is related to 179,428 warrants granted as a success fee with respect to theissuance of the convertible notes and private Investment.

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4)During the year ended December 31, 2019, the Company granted to several consultants 88,499 warrants each exercisable between $ 4.3 and $ 7.00 per share for three years. The fair value of those options as of the date of grant using the Black-Scholes valuationmodel was $ 155 thousand, out of which $ 97 thousand is related to 57,142 warrants granted as a success fee with respect to theissuance of the convertible notes.

5)In September 2019, the Company entered into an investor relation services, marketing and related services agreement. Under theterms of the agreement, the Company agreed to issue the consultant 40,174 shares of restrictedcommon stock, of which the first 20,087 shares will beheld in escrow by the Company until the six months anniversary of the agreement and 20,087 shares will beissued on the six months anniversary of the agreement to be held in escrow by the company until the one-year anniversary of theagreement. The fair value of the shares was $ 178 thousand usingthe fair value of the shares on the grant date. $ 96 and 82 thousand was recognizedduring the year ended December 31, 2020 and December 31, 2019, respectively.

6)In March 2019, the Company issued First Choice 525,000 shares of Common Stock. The value of Common Stock issued in the amountof $ 2.6 million were charged to research and development expenses during the year ended December 31, 2019.

7)In December 2018, the Company entered into an investor relation services, marketing and related services agreement. Under theterms of the agreement, the Company agreed to issue the consultant 10,000 shares of restricted common stock, of which the first 2,500 shares vested on the signing date, and 7,500 shares are to vest monthly over 3 months commencing January 2019. As of December31, 2019, 10,000 shares were fully vested. The fair value of the shares was $ 51 thousand using the fair value of the shares onthe vesting dates. $ 37 thousand was recognized during the year ended December 30, 2019.

8)In December 2018, the Company entered into a separate investor relations services, marketing and related services agreement. Underthe terms of the agreement, the Company agreed to issue the consultant 40,000 shares of restricted common stock, of which thefirst 6,667 shares vested on the signing date, and 33,333 shares vested monthly over five months commencing January 2019. As ofDecember 31, 2019, 40,000 shares were fully vested. The fair value of the shares was $ 200 thousand using the fair value of theshares at the vesting dates. $ 163 thousand was recognized during the year ended December 30, 2019.

9)During the year ended November 30, 2018, the Company granted to several consultants 78,782 warrants each exercisable between $ 6.24 and $ 15.41 per share for three years. The fair value of those warrants as of the date of grant using the Black-Scholes valuationmodel was $ 350 thousand. The warrants granted as a success fee with respect to private placement and the issuance of convertibleloans.

10)In January 2018, the Company entered into a consulting agreement with a financial advisor for a period of one year. Under theterms of the agreement, the consultant was entitled to receive $ 60 thousand and 19,000 units of the Company securities. Each unitis comprised of (i) one share of the Company’s common stock and (ii) a three -year warrant to purchase up to an additionalone share of the Company’s Common Stock at a per share exercise price of $ 6.24 . The fair value of the units as of the dateof grant was $ 171 thousand, out of which $ 62 thousand reflect the fair value of the warrants using the Black-Scholes valuationmodel. In July 2018, the board approved an additional issuance of 6,629 shares and three -year warrants to purchase up to 6,629 shares of the Company’s Common Stock at a per share exercise price of $ 6.24 . The fair value of the units as of the dateof grant was $ 88 thousand.

11)In December 2017, the Company entered into investor relations services, marketing and related services agreements. Under the termsof the agreement, the Company agreed to grant the consultants a total of 195,000 shares of restricted common stock, out of whichthe first 50,000 shares will vest after 30 days from the signing date, and 145,000 shares are to vest monthly over 15 months commencingFebruary 2018. As of December 31, 2019, all shares were vested. The fair value of the shares as of the date of grant was $ 1,439 thousand.

12)During the twelve months ended December 31, 2020, the Company issued 270,174 shares of common stock to service providers. As ofDecember 31, 2020, 30,000 shares have additional restrictions on transfer until such services have been provide.

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NOTE16 – TAXES

a.	Corporate taxation in the U.S.

Thecorporate U.S. Federal Income tax rate applicable to the Company and its US subsidiaries is 21 % .

Asof December 31, 2020, the Company has an accumulated tax loss carryforward of approximately $ 18 million (as of December 31, 2019,approximately $ 34 million).

ForU.S. federal income tax purposes, net operating losses (“NOLs”) arising in tax years beginning after December 31,2017, the Internal Revenue Code of 1986, as amended (the “Code”) limits the ability to utilize NOL carryforwards to80% of taxable income in tax years beginning after December 31, 2020. In addition, NOLs arising in tax years ending after December31, 2017 can be carried forward indefinitely, but carryback is generally prohibited. NOLs generated in tax years beginning beforeJanuary 1, 2018 will not be subject to the taxable income limitation, and NOLs generated in tax years ending before January 1,2018 will continue to have a two-year carryback and twenty-year carryforward period. Deferred tax assets for NOLs will need tobe measured at the applicable tax rate in effect when the NOL is expected to be utilized. The changes in the carryforward/carrybackperiods as well as the new limitation on use of NOLs may significantly impact the Company’s valuation allowance assessmentsfor NOLs generated after December 31, 2017.

Inaddition, utilization of the NOLs may be subject to substantial annual limitation under Section 382 of the Code due to an “ownershipchange” within the meaning of Section 382(g) of the Code. An ownership change, subjects pre-ownership change NOLs carryforwardsto an annual limitation, which significantly restricts the ability to use them to offset taxable income in periods following theownership change. In general, the annual use limitation equals the aggregate value of the Company’s stock at the time ofthe ownership change multiplied by a specified tax-exempt interest rate.

OnMarch 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted into law. TheCARES Act is aimed at providing emergency relief and health care for individuals and businesses affected by the COVID-19 pandemic.The CARES Act, among other things, includes provisions related to refundable payroll tax credits, deferral of the employer portionof social security payments, expanded net operating loss application, modifications to the net interest deduction limitations,and technical corrections to tax depreciation methods for qualified improvement property. The CARES act allowed the Company toutilize 100% of NOLs arising in tax years after December 31, 2017. The Company assess all other provisions of the CARES Act andnotes no other material impact to the Company.

b.	Corporate taxation in Israel

TheIsraeli Subsidiaries are taxed in accordance with Israeli tax laws. The corporate tax rate applicable to 2020 and 2019 are 23 % .

Asof December 31, 2020, the Israeli Subsidiaries has an accumulated tax loss carryforward of approximately $ 11 million (as of December31, 2019, approximately $ 10 million). Under the Israeli tax laws, carryforward tax losses have no expiration date.

c.	Corporatetaxation in Belgium

TheBelgian Subsidiary are taxed according to Belgian tax laws. The corporate tax rates applicable to 2020, 2019are 25 % and 29.58 %, respectively.

Asof December 31, 2020, the Belgian Subsidiary has an accumulated tax loss carryforward of approximately $ 8 million (€ 6 million), (as of December 31, 2019 $ 6 million). Under the Belgian tax laws thereare limitation on accumulated tax loss carryforward deductions of Euro 1 million per year.

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d.	Corporate taxation in Korea

Thebasic Korean corporate tax rates are currently: 10 % on the first KRW 200 million of the tax base, 20 % up to KRW 20 billion, 22 % up to KRW 300 billion and 25 % for tax base above KRW 300 billion. In addition, the local income tax rate is 1 % on the first KRW200 million of taxable income, 2 % on taxable income over KRW 200 million up to KRW 20 billion, 2.2 % of taxable income over KRW20 billion up to 300 billion and 2.5 % on taxable income over KRW 300 billion.

Asof December 31, 2020, the Korean subsidiary has an accumulated tax loss carryforward of approximately $ 4 million (KRW 3,813 million), (as of December 31, 2019,approximately $ 3 million). Under the Korean tax laws accumulatedtax loss can be carry forwarded for 15 years.

e.	Deferred Taxes

Thefollowing table presents summary of information concerning the Company’s deferred taxes as of the years ending December31, 2019 and December 31, 2019 (in thousands):

SCHEDULE OF DEFERRED TAX ASSETS

		2020				2019
		December 31,
		2020				2019
		(U.S. dollars in thousands)
Net operating loss carry forwards		$	9,606			$	14,033
Research and development expenses			1,684				1,358
Equity compensation			2,747				-
Employee benefits			252				228
Leases asset			533				-
Lease liability			( 324	)			-
Intangible assets			( 2,863	)			( 737	)
Other			297				( 1	)
Less: Valuation allowance			( 11,932	)			( 14,939	)
Net deferred tax liabilities		$	-			$	( 58	)

Realizationof deferred tax assets is contingent upon sufficient future taxable income during the period that deductible temporary differencesand carry forwards losses are expected to be available to reduce taxable income. As the achievement of required future taxableincome is not considered more likely than not achievable, the Company and all its subsidiaries except the Korean Subsidiary (previouslyCureCell) have recorded full valuation allowance.

Thechanges in valuation allowance are comprised as follows:

SCHEDULE OF VALUATION ALLOWANCE, ACTIVITY

		December 31,
		2020				2019
		(U.S dollars in thousands)
Balance at the beginning of year		$	( 14,939	)		$	( 10,254	)
Change during the year			3,007				( 4,685	)
Balance at end of year		$	( 11,932	)		$	( 14,939	)

f.	Reconciliation of the Theoretical Tax Expense to Actual Tax Expense

Themain reconciling item between the statutory tax rate of the Company and the effective rate is the provision for valuation allowancewith respect to tax benefits from carry forward tax losses.

g.	Uncertain Tax Provisions

ASCTopic 740, “Income Taxes” requires significant judgment in determining what constitutes an individual tax positionas well as assessing the outcome of each tax position. Changes in judgment as to recognition or measurement of tax positions canmaterially affect the estimate of the effective tax rate and consequently, affect the operating results of the Company. As ofDecember 31, 2020, the Company has not accrued a provision for uncertain tax positions.

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NOTE17 – REVENUES

Disaggregationof Revenue

Thefollowing table disaggregates the Company’s revenues by major revenue streams.

SCHEDULE OF DISAGGREGATION OF REVENUE

		Year Ended December 31,
		2020				2019
		(in thousands)
Revenue stream:
POC and hospital services		$	6,068			$	3,109
Cell process development services			1,584				790
Total		$	7,652			$	3,899

POCdevelopment services are the result of agreements between Company and its partners (See Note 11). The Company provides certainservices in support of the partners’ clinical activity. The Company has signed Master Services Agreements with joint venturepartners in the aggregate amount of over $ 38 million for services to be provided from 2021 to 2022.

Abreakdown of the revenues per customer what constituted at least 10% of revenues is as follows:

SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER

		Year Ended December 31,
		2020				2019
		(in thousands)
Revenue earned:
Customer A		$	2,857			$	1,420
Customer B			1,577				-
Customer C – related party			1,475				1,270
Customer D			1,412				857

ContractAssets and Liabilities

Contractassets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currentlydue from customers.

Theactivity for trade receivables is comprised of:

SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES

		Year Ended December 31,
		2020				2019
		(in thousands)
Balance as of beginning of period		$	1,831			$	129
Acquisition of Koligo			228				-
Additions			6,997				2,079
Collections			( 5,982	)			( 364	)
Exchange rate differences			11				( 13	)
Balance as of end of period		$	3,085			$	1,831

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Theactivity for contract liabilities is comprised of:

SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES

		Year Ended December 31,
		2020				2019
		(in thousands)
Balance as of beginning of period		$	325			$	56
Additions			597				1,126
Realizations*			( 862	)			( 854	)
Exchange rate differences			( 1	)			( 3	)
Balance as of end of period		$	59			$	325

*	Out of which $ 325 thousand were realized from the beginning of the period for the year ended December 31, 2020.

NOTE18 – COST OF RESEARCH AND DEVELOPMENT AND RESEARCH AND DEVELOPMENT SERVICES, NET

SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSES

		Year Ended December 31,
		2020				2019
		(in thousands)
Total expenses		$	84,182			$	14,826
Less grants			( 196	)			( 812	)
Total		$	83,986			$	14,014

NOTE19 – FINANCIAL EXPENSES, NET

SCHEDULE OF FINANCIAL EXPENSES

		2020				2019
		Year Ended December 31,
		2020				2019
		(in thousands)
Increase in fair value of warrants and financial liabilities measured at fair value		$	-			$	63
Interest expense on convertible loans			1,254				498
Foreign exchange loss, net			160				395
Other income			( 353	)			( 113	)
Total		$	1,061			$	843

NOTE20 – RELATED PARTIES TRANSACTIONS

a.	Related Parties presented in the consolidated statements of comprehensive loss

SCHEDULE OF RELATED PARTY TRANSACTIONS

		Year ended December 31,
		2020				2019
		(in thousands)
Continuing operations:
Stock-based compensation expenses to executive officers		$	221			$	898
Stock-based compensation expenses to Board Members*		$	209			$	414
Compensation of executive officers		$	1,321			$	812
Management and consulting fees to Board Members		$	264			$	233
Revenues from customer		$	1,475			$	1,270
Cost of research and development and research and development services, net		$	4,772			$	-
Financial income		$	169			$	112

*	Does not include $ 192 thousand for the year ended December 31, 2019 related to Stock Based Compensation expenses for options exercisable at an exercise price of $ 7.00 per share into 70,000 ordinary shares held by Caerus Therapeutics LLC for which the director does not have beneficial control.

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		Year ended December 31,
		2019
		(in thousands)
Discontinued operations:
Stock-based compensation expenses to executive officers		$	76
Compensation of executive officers		$	685

b.	Related Parties presented in the consolidated balance sheets

SCHEDULE OF RELATED PARTIES PRESENTED IN CONSOLIDATED BALANCE SHEETS

		December 31,
		2020				2019
		(in thousands)
Continuing operations:
Executive officers’ payables		$	170			$	1,251
Non-executive directors’ payable		$	13			$	202
Loan to Related Party		$	-			$	2,623
Accounts receivable, net		$	744			$	-
Contract liabilities		$	-			$	230

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